United States Patent (19) 11 Patent Number: 4,790,327 Despotis (45) Date of Patent: Dec

United States Patent (19) 11 Patent Number: 4,790,327 Despotis (45) Date of Patent: Dec. 13, 1988

(54) ENDOTRACHEAL INTUBATION DEVICE Attorney, Agent, or Firm-Mason, Kolehmainen, 76) Inventor: George Despotis, 5320 N. Sheridan Rathburn & Wyss Rd., Apt. 806, Chicago, Ill. 60640 (57) ABSTRACT An endotracheal intubation device for determining cor (21) Appl. No.: 78.256 rect placement of an endotracheal tube in the trachea, 22 Filed: Jul. 27, 1987 or windpipe, of a medical patient by detecting the pres ence of carbon dioxide in expired air. The portable, (51 Int. Cl."...... A61M 16/00 reusable endotracheal intubation device includes a ma 52 U.S. Cl...... 128/719; 128/205.23; terial capable of physically and/or chemically interact 128/207.16; 422/85 ing with carbon dioxide, such as barium hydroxide or 58) Field of Search ...... 128/207.14, 207.15, calcium oxide, and a visual indicating material, such as 128/207.17, 205.23, 719, 207.16; 436/133; an acid-base indicator that changes color in relation to 422/85, 55, 56, 58 pH changes, like ethyl violet or thymolphthalein, (56) References Cited whereby the visual indicating material changes color in response to the interaction of the carbon dioxide with U.S. PATENT DOCUMENTS the interactant material. The visual color change of the 2,890,177 6/1959 Kilmer ...... 436/133 chemical reagent materials present in the endotracheal 4,619,269 10/1986 Cutler et al. ... 128/205.23 intubation device confirms the placement of the endo 4,691,701 9/1987 Williams. ... 128/2O7.14 X tracheal tube within the trachea as opposed to within 4,728,499 3/1988 Fehder ...... 128/207. 14 X the esophagus. Primary Examiner-A. Michael Chambers Assistant Examiner-John C. Fox 42 Claims, 2 Drawing Sheets

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SNN\(\Šf M 1. 4,790,327 1. 2 initially, during CPR (cardiopulmonary resucitation), ENDOTRACHEAL INTUBATON DEVICE involving relatively large chest movement of the pa tient, tracheal tube migration may occur with resultant BACKGROUND OF THE INVENTION extubation. 1. Field of the Invention The overall result of esophageal intubation, or inad The present invention relates to an endotracheal intu vertent endotracheal extubation, is the direct failure of bation device that verifies placement of the endotra both preventing aspiration of stomach contents and cheal tube in the trachea, or windpipe, of a medical protecting the airway that provides ventilation for the patient. More particularly, the endotracheal intubation patient. Therefore, the consequences are the aspiration device includes a suitable carbon dioxide absorbent that 10 of stomach contents, resulting in pneumonia, and the can physically and/or chemically interact with the car lack of ventilation, leading to brain damage and death bon dioxide and a suitable visual indicator for detecting unless endotracheal tube placement is quickly remedied. carbon dioxide absorption. By attaching the endotra A number of clinical tests, as discussed in the Bir cheal intubation device to an endotracheal tube, place mingham et al. publication, are available to verify ment of the endotracheal tube within the trachea, as 15 proper tube placement within the trachea. Among the opposed to within the esophagus, is verified by visually several clinical tests discussed, actual visualization of observing the color change of the chemical reagents, the endotracheal tube passing the vocal chords is of comprised of the carbon dioxide absorbent and the primary clinical importance. However, neither this test visual indicator. The incorrect placement of the endo nor any of the other clinical tests is fail-safe. It has been tracheal tube into the esophagus will not produce the 20 found however that the most definitive verification of visual color change because the carbon dioxide, present correct tube placement involves an analysis for carbon in the exhalations of the patient, is not available to dioxide gas including end-tidal carbon dioxide devices, contact the indicator treated carbon dioxide absorbent. in combination with mass spectometric carbon dioxide 2. Description of the Prior Art analysis. Endotracheal intubation is a routinely performed 25 During normal ventilation, oxygen inhalation pro procedure, and one of the first techniques taught to the vides oxygen for normal metabolic needs. When the anesthesia trainee. Today the technique is performed by metabolic by-products, predominantly carbon dioxide, individuals having different backgrounds and levels of training in the operating suite, emergency room, inten are moved by exhalation, the end-tidal and mass spec sive care unit, hospital ward and in the field. 30 tometric techniques afford the medical practitioner However, the frequency of tracheal intubation in both qualitative and quantitative evaluation of the ex modern anesthetic practices belies its importance. Al haled gases, including the gas of primary concern, car though endotracheal intubation is performed routinely bon dioxide. in anesthesia, endotracheal intubation is a dangerous At present, end-tidal carbon dioxide measurement is procedure and often does not receive the respect and 35 the most reliable means of determining proper tube attention it deserves. Anesthetic-related disability and position and is routinely employed when possible. How mortality statistics indicate that unrecognized esopha ever, the instruments utilized in these techniques are geal intubation, as opposed to endotracheal intubation, both extremely expensive and cumbersome in size. As a remains a problem, even among anesthesia personnel result, although Eichhorn et al., in JAMA, Vol. 256, specifically trained in such a procedure. 40 Issue 8, pages 1017 to 1020, have deemed carbon diox Undiagnosed esophageal intubation continues to fig ide analysis as one of the standards of medical care, ure predominantly in anesthesia related morbidity and many present-day operating rooms and clinics are not mortality. Birmingham, et al., in Anesth Analg., Vol. 65, equipped with these carbon dioxide detection devices. page 886 to 891 (1986), reviews the various detection Several investigators have attempted to make verifi techniques for differentiating between endotracheal and 45 cation of endotracheal tube placement both accurate esophageal tube placement, and found that most of the and inexpensive. In Russian Pat. No. 157,059, an endo commonly utilized methods of verifying tube position tracheal device is disclosed that includes a whistle to have been shown to fail under certain circumstances. verify that the tube is actually inserted in the trachea The verification of correct tube placement within the and not in the gullet. The whistle serves to give out a trachea is a major problem for anesthesia and emer 50 sound during exhalation and inhalation thereby con gency personnel involved in endotracheal intubation. firming the presence of the tube in the trachea. The lack Both in surgical and emergency situations, intubation of of a sound indicates that the tube has been placed within the trachea often is necessary because normal airway the esophagus as opposed to the trachea. However, this protective reflexes have been lost, and therefore, trach device has several drawbacks including sound genera eal intubation is required both to protect against aspira 55 tion by stomach gases, therefore giving a false positive tion of stomach contents and for ventilation. placement of the tube; a device that can be clogged by However, because of the human anatomy, an attempt secretions; a device and method that most likely is inef at endotracheal intubation may easily result in esopha fective on a collapsed lung; a method that relies on the geal intubation. The anatomic proximity of the trachea increase in thoracic gas pressure and not upon the anal and the esophagus facilitates inadvertent esophageal 60 ysis of an end-tidal gas, thereby requiring a disconnect intubation during certain circumstances. For example from the ventilator or the stopping of cardiopulmonary the standard method of determining correct tube place resucitation to check for correct placement; and a de ment is visualization of the vocal chords. However, vice that is not reusable. when the vocal chords cannot be visualized due to an Gallagher, in U.S. Pat. No. 3,373,735, discloses a atypical anatomy, excessive excretions or poor laryn 65 medical-surgical tube including a color change acid goscopy technique by inexperienced personnel, verifi based indicator, such that placement of the tube cation of proper tube placement is essential. In addition, through the patient's nostrils into the patient's stomach although the trachea may have been correctly intubated can be verified. The placement of the tube within the 4,790,327 3 4. stomach is verified by the color change of the indicator endotracheal tube placement by analyzing the exhala in response to the low stomach pH of approximately 1 tions of the medical placement for the presence of car to 2. Incorrect placement of the tube in the lungs will bon dioxide. not produce the color change because the pH range in Another object of the present invention is to provide the lungs varies from approximately 7.45 to approxi 5 an endotracheal intubation device that analyzes the mately 8.15. This device also suffers from serious draw exhalations of the patient for carbon dioxide by a physi backs including the need for the sometimes absent se cal and/or chemical interaction of the carbon dioxide cretions to cause a pH change, as opposed to analyzing with an absorbent that changes pH in response to car an always present gas. In addition, incorrect results can bon dioxide absorption, and therefore induces a color occur because of secretions having a low pH being 10 change in a visual indicator. aspirated into the trachea or lungs. Other disadvantages Another object of the present invention is to provide include the possibility of clogging, the need to discon an endotracheal intubation device that can be used in nect the ventilating device, the device is not reusable hospitals, clinics, physician's offices and ambulances to and the possibility of trauma due to the deep insertion of qualitatively check patient exhalations for carbon diox the device. 5 ide, and therefore verify correct endotracheal tube McCormick, in U.S. Pat. No. 4,431,005, discloses a placement within the trachea. method and apparatus for determining the position of a Another object of the present invention is to provide device within biological tissue by using an electromag an endotracheal intubation device that can be used by netic detecting device. This type of device suffers from highly trained medical personnel or by relatively un the disadvantages of being fragile, expensive and sta 20 trained emergency personnel. tionary as opposed to portable. Furthermore, the Still another object of the present invention is to method will only verify the height of the tube within provide an endotracheal intubation device that is eco the biological tissue, but not the depth of the tube nomical, portable and reusable. within the biological tissue. Therefore, the method is In brief, the present invention is directed to an endo potentially insufficiently accurate to distinguish be 25 tracheal intubation device that overcomes the disadvan tween tracheal and esophageal placement. tages of the prior art systems in verifying the correct British Pat. No. 345,672 discloses the use of an absor placement of the endotracheal tube within the trachea, bent, containing a visual indicator, for detecting and for as opposed to within the esophagus. The present inven removing the water vapor in air or a gas. When the tion is used for prompt and accurate determination of absorbent changes color, the absorbent is saturated with 30 endotracheal tube placement, thereby reducing the water vapor, indicating that fresh absorbent should be frequency of anesthetic accidents resulting in death or added to the device in order to keep the air or gas dry. cerebral damage because of faulty placement of the From the scope of the prior art, it is apparent that endotracheal tube during surgery or emergency treat there is a need for a device that accurately and quickly IrentS. verifies the correct placement of an endotracheal tube 35 More particularly, the present invention is directed to within the trachea both at the time of initial placement an endotracheal intubation device that can be attached and at any time thereafter during treatment. Although to the endotracheal tube and to a ventilator such as an some such devices are presently available, they are Ambu-bag, and that can be used to verify correct endo expensive, bulky and require trained personnel for tracheal tube placement within the trachea. The device proper usage. Therefore, for small hospitals, clinics, includes a chemical reagent comprising a carbon diox private physicians and emergency personnel, such as ide absorbent, such as barium hydroxide or calcium paramedics, it would be highly desirable to have an oxide, and a visual indicator, such as ethyl violet or economical, reusable and portable device that quickly thymolphthalein, to physically and/or chemically ine and accurately verifies correct endotracheal tube place ract with carbon dioxide exhaled by the patient and ment that can be used by either highly trained or rela 45 cause a color change in response to a pH change caused tively untrained medical personnel. by carbon dioxide ineraction with the absorbent. A color change by the absorbent verifies endotracheal SUMMARY OF THE INVENTION tube placement, while the absence of a color change Therefore, it is an object of the present invention to indicates placement within the esophagus. Esophageal provide an endotracheal intubation device useful in 50 placement precludes patient exhalation of carbon diox verifying the correct placement of endotracheal tube ide through the endotracheal tube device of the present within the trachea. invention, thereby making carbon dioxide contact with Another object of the present invention is to provide the absorbent in the color change impossible. an endotracheal intubation device that eliminates or minimizes errors in placement of the endotracheal tube 55 BRIEF DESCRIPTION OF THE DRAWING during surgical or emergency treatment. These and other objects and advantages of the pres Another object of the present invention is to provide ent invention will become readily apparent upon con an endotracheal intubation device that eliminates the sideration of the following detailed description and possibility of giving an incorrect verification of endo attached drawing wherein: tracheal tube placement within the trachea. 60 FIG. 1A is a cross-section of a patient's head and Another object of the present invention is to provide throat illustrating the esophagus and trachea at the an endotracheal intubation device that verifies both initial stage of laryngoscopy; correct initial endotracheal tube placement and correct FIG. 1B is a cross-section of a patient's head and tube placement throughout the entire medical proce throat illustrating the esophagus and trachea at a final dure without the need to interrupt the procedure and to 65 stage of laryngoscopy; recheck for the correct tube placement. FIG. 2 is a sectional view of the endotracheal intuba Another object of the present invention is to provide tion device of the present invention connected to a an endotracheal intubation device that verifies correct source of supply air and an endotracheal tube; 4,790,327 5 6 FIG. 3 is a plan view of the endotracheal device passageway 18 in the endotracheal intubation device 10 taken along lines 3-3 of FIG. 2; to the proximal end 20 of the endotracheal tube 14 in the FIG. 4 is a cross-sectional view of the endotrachael direction indicated by the arrow 16. During exhalation, device taken along lines 4-4 of FIG. 2; air flows in the direction of the arrow 22 through the FIG. 5 is a cross-sectional view of the endotracheal 5 exhalation air passageway 24 and passes through a vi device taken along lines 5-5 of FIG. 2; sual indicator 26, which analyzes for the presence of FIG. 6 is an exploded perspective view of the endo carbon dioxide, before being vented to the atmosphere. tracheal device in accordance with the present inven Thus, if the presence of carbon dioxide is indicated by tion; the visual indicator 26, correct placement of the endo FIG. 7 is an exploded perspective view of an air 10 tracheal tube in the trachea is verified. manifold which forms a portion of the endotracheal The endotracheal intubation device 10 of the present intubation device in accordance with the present inven invention is comprised of generally a tubular device tion; having three ports; an air supply port 30, a patient port FIG. 8 is a fragmentary plan view of an alternative 32 and an exhalation port 34. The patient port 32 and embodiment of the visual indicator illustrated in FIG. 3; 15 the air supply port 30 are adapted to mate with standard FIG. 9 is a plan view of another alternative embodi size male connectors of an endotracheal tube 14 and an ment of the visual indicator illustrated in FIG. 3 shown air supply source, such as an Ambu-bag 12, respec with airtight end caps; tively. Specifically, the inner diameter of the patient FIG. 10 is a plan view of yet another alternative port 32 may be formed to be 15 mm in diameter to mate embodiment of the visual indicator illustrated in FIG. 3, with an endotracheal tube having a male connector shown encapsulated in an airtight container; and sleeve 36 with an outer diameter 15 mm, while the air FIG. 11 is a plan view of still another alternative supply port 30 may be formed to mate with a 22 mm embodiment of the visual indicator illustrated in FIG. 3, diameter Ambu-bag male connector sleeve 38. The shown with the end caps sealed with tape. different size diameters for the air supply port 30 and 25 the patient port 32 may be effected either by forming DETAILED DESCRIPTION the endotracheal intubation device 10 with a non The invention relates in general to a portable endotra uniform wall thickness as shown in FIG. 2 or by using cheal intubation device adapted to be used by physi an intermediate connector (not shown) between the cians, paramedics and the like to continuously verify the patient port 30 and the Ambu-bag 12 and between the correct placement of an endotracheal device within the 30 patient port 32 and the endotracheal tube 14. trachea of a patient when other expensive equipment, In the embodiment illustrated in FIG. 2, the thickness such as an end-tidal device or a mass spectrometer, is of the wall 40 of the endotracheal intubation device 10 not available. The correct placement of the endotra is greater at the patient port 32 than at the air supply cheal tube in the trachea of a patient is verified by de port 32 because of the smaller inner diameter required at tecting for presence of carbon dioxide at the proximal 35 the patient port 32. The thicker wall portion 40 at the end of the endotracheal tube, which extends from the patent port 32 defines an annular shoulder 42 for seating breathing passageway of a patient. The endotracheal against flange 44 at the proximal end 20 of the endotra intubation device of the present invention is further cheal tube 14. The connection between the male con adapted to provide continuous monitoring of the endo nector sleeve 36 at proximal end 20 of the endotracheal tracheal tube to detect for migration of the endotracheal tube 14 and the patient port 32 may be either threaded tube from the trachea, which may occur during various or a friction fit to provide an airtight connection there circumstances, such as during cardiopulmonary resusci between. The wall portion 41 proximate of the air sup tation. ply port 30 also defines an annular shoulder 46 for seat Referring to the drawing, FIGS. 1A and 1B illustrate ing against a flange 48 on the Ambu-bag 12. The con the trachea and esophagus of a patient during the initial 45 nection may be either threaded or a compression fit to and final stages of laryngoscopy, respectively. A laryn provide an airtight connection between the Ambu-bag goscope may be used to facilitate endotracheal intuba 12 and the air supply port 30. tion by providing a guide channel from the mouth to the The endotracheal intubation device 10 in accordance trachea through which an endotracheal tube may be with the present invention is comprised of a first tubular inserted. However, due to the close proximity of the 50 member 50 and a second tubular member 56. The first trachea and the esophagus, inadvertant esophageal intu tubular member defines an air supply port 30 at one end bation may occur due to various anatomical factors or and a patient port 32 at the other end. The first tubular due to the lack of experience of the person performing member 50 also defines an inhalation air passageway 18 the laryngoscopy. Oftentimes, correct placement of disposed between the patient port 32 and the air supply endotracheal intubation must be verified by emergency 55 port 30 which allows air communication between the medical technicians in an ambulance or other location source of air 12 and the endotracheal tube 14. As will be where there is no access to a conventional machine, described in detail below, the first tubular member 50 such as an end-tidal device or a mass spectrometer. The also defines a portion of an exhalation air passageway 24 present invention provides a portable, inexpensive, reli by providing a passageway between the endotracheal able and continuous method to verify endotracheal 60 tube 14 to the exhalation port. A circular aperture 51 intubation. (FIG. 7) in the wall of the first tubular member 50 is Referring to FIG. 2, the endotracheal intubation adapted to receive a second tubular member 56.27 such device of the present invention is generally identified by that the longitudinal axis of the first tubular member 50 the reference numeral 10. This device is inserted be is substantially perpendicular to the longitudinal axis of tween a source of air 12, such as an Ambu-bag or an air 65 the second tubular member 56. A flat 55 (FIGS. 4 and 5) turbine (not shown) and an endotracheal tube 14. Dur may be used to insure proper orientation of the first ing inhalation, artificial respiration air is supplied from intubular member 50 with respect to the second intubu the source of air supply 12 through an inhalation air lar member 56. A flange 57 formed integral with the d 4,790,327 7 8 second tubular member 56 seats against the exterior A filter 74 is preferably disposed between the end cap wall of the first tubular member 46, thus allowing the 68 and the second valve 60 to prevent inhalation of dust second tubular member 56 to be in communication with from the chemical reagent 66. The filter 74 may be the patient port 32 via a portion of the first tubular disposed either within the visual indicator 26 or within member 50, which together define an exhalation air the tubular member 56. The filter 74 may be comprised passageway 24 between the proximal end 20 of the of any non-toxic material that both prevents the inhala endotracheal tube 14 and the exhalation port 34. A tion of dust and does not restrict the exhalations of the bracket 59 (FIGS. 6 and 7) may be used to secure the patient. The filters can be made of glass wool, loosely first tubular member 50 to the second tubular member packed cotton, loosely-packed filter paper and other 56. 10 like materials. In order to direct the exhaled air through the exhala In the embodiment illustrated in FIGS. 2, 3 and 6, the tion air passageway 24, a diverter valve 58 (FIGS. 2-5) visual indicator 26 is removable from the second tubular is disposed within the first tubular member 50, which is member 56. However, it will be appreciated by those of responsive to air flow in the direction of the arrow 16, ordinary skill in the art, the principles of the invention to close the end of the second tubular member 56 and, 15 are equally applicable to an endotracheal intubation consequently, the exhalation port 34 during inhalation. device 10 formed with an integrally formed visual indi During exhalation, the diverter valve 58 is spring biased cator 26. However, there are several advantages of to close the air supply port 30 to preclude exhaled air using a removable visual indicator 26. First, the visual from backflowing into the air supply 12 during exhala indicator 26 can be easily removed allowing the exhala tion. A check valve 60 (FIGS. 2, 3 and 8) may be pro 20 tion port 34 to be easily connected to an end-tidal de vided within the second tubular member 56 to prevent vice and a mass spectrometer, or the like, once the inhalation through the second tubular member 56 in the patient arrives at the hospital for continuous quantita event of a spontaneous breath by the patient during an tive and qualitative carbon dioxide analysis. Secondly, the visual indicator 26 can be either regenerated or exhalation cycle (e.g., when there is no air flow from 25 discarded allowing the non-rebreathing valve to be the source of air supply 12). The aforementioned combi autoclaved or otherwise sterilized and reused. nation of the tubular members 50 and 56 and cooperat In order to prevent the chemical reagent 66 from ing valves 58 and 60 define a manifold for providing an being actuated prior to being placed in use, the chemical inhalation air passageway 18 and an exhalation air pas reagent 66 must be protected from the atmosphere This sageway 24. Such manifolds are known in the art as 30 can be accomplished in a number of different ways. For non-rebreathing valves and are available from Instru example, the visual indicator 26 may be packaged in an mentation Industries in Bethel Park, Pa. airtight container 73 (FIG. 10) or by providing remov As shown in FIGS. 2, 3 and 6, the visual indicator 26 able solid end caps 75 (FIG. 9) that are adapted to be is connected to the distal end 61 of the tubular member removed prior to use. If the visual indicator 26 is sealed 56 and is comprised of a tubular member 62 which 35 with removable solid end caps 75, the end cap 72 must defines a cylindrical cavity 64 for receiving a chemical be disposed inside the tubular member 62, similar to the reagent 66 for indicating the presence of carbon diox other end cap 68, to allow the removable solid end cap ide. An end cap 68, disposed inside and intermediate one to be fit on the outside of the tubular member 62. The end of the tubular member 62, defines a female connec visual indicator 26 may also be sealed with tape 76 as tor 70 for connection to the exhalation port 34. The shown in FIG. 11. inner diameter of the tubular member 56 is sized to be Regarding the chemical reagent 66, various chemical received into the female connector 70. By utilizing reagents are adapted to be within the breadth and scope larger diameter for the visual indicator 26, the air flow of the present invention. For example, in one embodi resistance is decreased from the inhalation port 34 to ment, the chemical reagent comprises calcium oxide mitigate the flow resistance caused by the chemical 45 and thymolphthalein on an inert support such as sand reagent 66 within the visual indicator 26. Alternatively, and/or glass beads. In this embodiment, the exhaled as shown in FIG. 8, the outer diameter of the visual carbon dioxide contacts and is physically and/or chemi indicator 26 may be made smaller than the diameter of cally absorbed by the calcium oxide. The resulting ine the tubular member 56 to be received therewithin. With raction produces a pH change that changes the color of either embodiment, the connection between the second 50 the chemical reagents from blue to white. In another tubular member 56 and the visual indicator 26 may be embodiment, the chemical reagents comprise barium by friction fit or by threaded connection. The end cap hydroxide and ethyl violet on a suitable support. In this 68, among other things, limits the travel of the second embodiment, the presence of carbon dioxide, and there tubular member 56 within the female connector 70 of fore verification of the endotracheal tube within the the visual indicator 26. Another end cap 72 is disposed 55 trachea, is seen in a color change of white to purple. at the other end of the tubular member 62 of the visual In general, the chemical reagents of the present in indicator 26 defining a cavity 64 for receiving the chem vention can be any compound that absorbs and reacts ical reagent 66. Each of the end caps 68 and 72 are air with the gaseous carbon dioxide, thereby producing a permeable to allow expired air to pass from the patient pH change and a color change in the visual indicator. through visual indicator 26 containing the chemical 60 Because of the slightly acidic nature of carbon dioxide, reagent 66 to the atmosphere. The end cap 68 may be the carbon dioxide-absorbing chemical is usually alka formed integral with the tubular member 62 or may be line in nature in order to ensure a rapid and total reac formed separately and secured to the inner wall thereof tion with carbon dioxide, and to ensure a sufficient pH with an appropriate adhesive or by ultrasonic welding. change to change the color of the visual indicator. The The end cap 72 is formed separately and affixed to the 65 carbon dioxide absorbent compounds that can be used tubular member 62 after the chemical reagent 66 has in the device of the present invention include the oxides been placed in the cylindrical cavity 64 within the indi and hydroxides of the alkali metals and alkaline earth cator 26. metals, such as barium oxide, barium hydroxide, cal 4,790,327 10 cium oxide, calcium hydroxide, sodium hydroxide, is connected to the air supply port 30. The visual indica magnesium oxide, potassium hydroxide, lithium hy tor 26 is removed from its airtight container (or the droxide and combinations thereof. Similarly amphoteric airtight solid end caps or tapes are removed) and the oxides or hydroxides of the transition metals that can visual indicator is connected to the exhalation port 34. react with carbon dioxide, such as zinc oxide, can also Resuscitation is then commenced. As resuscitation air be used either alone or in combination with the alkali flows from the air supply 12 through the inhalation air metal and alkaline earth oxides and hydroxides. Simi passageway 18, the diverter valve 58 is forced open to larly, commercially available hydrazinc compounds, allow the air to flow to the patient port 32 and into the such as those used in the Drager tube atmosphere ana proximal end 20 of the endotracheal tube 14. If the lyzing device, available from Dragerwerk A.G., Lu 10 endotracheal tube 14 is properly inserted into the tra beck, Germany, can be used in accordance with the chea, carbon dioxide will be exhaled by the patient and present invention. expelled through the endotracheal tube 14 into the pa A visual indicator also must be included in the device tient port 32. During exhalation, the diverter valve 58 of the present invention in order to visually detect the closes the inhalation port 30 under the influence of a interaction of the exhaled carbon dioxide with the car spring and defines an exit passageway for the carbon bon dioxide absorbing compound. The indicator will dioxide from the patient port 32 to the visual indicator change color in relation to a pH change that occurs 26. The carbon dioxide reacts with the chemical agent when the carbon dioxide absorbing compound react causing a pH change resulting in a color change of the with the exhaled carbon dioxide. Normally, the visual visual indicator. This indicates the presence of carbon indicator will exhibit its alkaline color within the device 20 dioxide and verifies correct placement of the endotra of the present invention until the carbon dioxide cheal tube within the trachea. Another valve 60 in the contacts and reacts with the absorbent compound, caus exhalation passageway 24 prevents inhalation through ing a chemical reaction and pH drop. The visual indica the exhalation passageway 24 due to a spontaneous tor will then change color to its acidic color. The partic breathing by the patient. If the exhalation tube is in the ular visual indicator to be used will vary according to 25 trachea the visual indicator will so indicate. the absorbent compound used; however, indicators Thus, it should be apparent that an endotracheal normally changing color in a pH range of about 8 to intubation device has been disclosed which can be used about 11.5, and preferably in a pH range of about 9 to to verify the placement of an endotracheal tube within about 10.5, can be used in the device of the present the trachea in an easy and inexpensive manner. As here invention. These visual indicators include ethyl violet, 30 tofore discussed, the system can be implemented in a thymolphthalein, alizarin yellow, phenolphthalein, thy number of ways, all of which are contemplated to be mol blue, ethyl bis(2,4-dimethylphenol)acetate, p-naph within the scope of the appended claims. thol benzene, o-cresolphthalein and alizarin. Gradua What is claimed and desired to be secured by Letters tions 78 (FIG. 9) may be disposed on the tubular mem Patent of the United States is: ber 62 to prove a quantitative indication of carbon diox 35 1. A portable endotracheal intubation device for veri ide. fying the correct placement of an endotracheal tube in The analysis of exhaled carbon dioxide by either the trachea of a patient comprising: conventional capnographs, mass spectrometry or the an endotracheal tube having a proximal end adapted proposed portable method which has been described to extend from the breathing passageway of a pa has limitations. First, during low cardiac output states, 40 tient and a distal end adapted to extend into the such as during cardiac arrest circumstances and diag trachea of a patient; nosed pulmonary embolus, the perfusion of the pulmo means for supplying air to said endotracheal tube; nary circulation is compromised leading to a lower than means including a patient port, air supply port and an normal value for exhaled carbon dioxide, ranging from exhalation port, adapted to be connected to said air 20-30 Tor., as opposed to a normal 40 Tor. In addition, 45 supply means and said endotracheal tube for pro patients that have had a cardiac arrest usually are venti viding an air inhalation passageway between the lated by mouth-to-mouth or by mask prior to intubation, patient port and said air supply port and for provid which may result in a small amount of carbon dioxide ing an air exhalation passage way between said within the stomach or the esophagus. This could poten patient port and said exhalation port, wherein said tially result in a false positive result by any form of SO exhalation port is in communication with the atmo exhaled carbon dioxide analysis. The carbon dioxide sphere and is isolated from said air supply port concentrations in this circumstance would be extremely during exhalation; and low (e.g. 5-10 Tor.) and would approach zero within a means serially coupled between said exhalation port few breaths. The addition of the graduations 78 give a and said atmosphere for providing a visual indica quantitative analysis which delineates correct endotra 55 tion of the placement of the endotracheal tube in cheal tube placement in the circumstances stated above. the trachea of the patient comprising a visual indi If there is a questionable result, another reagent car cating material which changes color in the pres tridge can be inserted to reaffirm endotracheal tube ence of carbon dioxide. placement. 2. A portable endotracheal intubation device as re All the materials used to make the endotracheal intu cited in claim 1 wherein said visual indication means bation device, of course, must be made from a non-toxic includes means for quantitatively displaying the pres and inert material, such as polycarbonate, PVC or other ence of carbon dioxide. suitable materials. The materials should also be suitable 3. An endotracheal intubation device as recited in for autoclaving and other sterilization techniques. claim 1, wherein said air supply means comprises a In operation, following laryngoscopy, the endotra 65 manually operable Ambu-bag. cheal tube is inserted into the trachea of the patient. The 4. An endotracheal intubation device as recited in patient port 32 is connected to the proximal end 20 of claim 1 wherein said air supply means comprises a me the endotracheal tube 14 and the source of air supply 12 chanically operated device. 4,790,327 11 12 5. An endotracheal intubation device as recited in reaction of the visual indicating material prior to patient claim 4, wherein said mechanically operated device Se. comprises an air turbine. 13. An endotracheal device as recited in claim 10, 6. An endotracheal intubation device for verifying wherein said visual indicating means is sealed with re the correct placement of an endotracheal tube in the movable tape. trachea of a patient comprising: 14. An endotracheal device as recited in claim 10, an endotracheal tube having a proximal end adapted wherein said visual indicating material is selected from to extend from the breathing passageway of a pa the group consisting of ethyl violet, thymolphthalein, tient and a distal end adapted to extend into the alizarin yellow, phenolphthalein, thymol blue, ethyl trachea of a patient; 10 bis(2,4-dimethylphenol)acetate, p-naphthol benzene, means for supplying air to said endotracheal tube; o-cresolphthalein and alizarin. means including a patient port, air supply port and an 15. A portable endotracheal intubation device for exhalation port, adapted to be connected to said air verifying the correct placement of an endotracheal tube supply means and said endotracheal tube for pro in the trachea of a patient comprising: viding an air inhalation passageway between the 15 an endotracheal tube having a proximal end adapted patient port and said air supply port and for provid to extend from the breathing passageway of a pa ing an air exhalation passageway between said tient and a distal end adapted to extend into the patient port and said exhalation port; trachea of a patient; means in communication with said exhalation port for means for supplying air to the proximal end of said providing a visual indication of the placement of 20 endotracheal tube; the endotracheal tube in the trachea of the patient an air manifold having an inhalation port adapted to comprising visual indicating material which communicate with said air supply means, a patient changes color in the presence of carbon dioxide; port adapted to be connected to the proximal end and of said endotracheal tube, and an exhalation port in 25 communication with the atmosphere, wherein said means for preventing air flow in the direction from exhalation port isolated from said inhalation port the exhalation port toward the patient port. during exhalation; and 7. An endotracheal device as recited in claim 1, fur a visual indicator in communication with said exhala ther including means for preventing inhalation of parti tion port which changes color in the presence of cles from said visual indicating means. 30 carbon dioxide. 8. An endotracheal intubation device for verifying 16. An endotracheal intubation device for verifying the correct placement of an endotracheal tube in the the correct placement of an endotracheal tube in the trachea of a patient comprising: trachea of a patient comprising: an endotracheal tube having a proximal end adapted an endotracheal tube having a proximal end adapted to extend from the breathing passageway of a pa 35 to extend from the breathing passageway of a pa tient and a distal end adapted to extend into the tient and a distal end adapted to extend into the trachea of a patient; trachea of a patient; means for supplying air to said endotracheal tube; means for supplying air to the proximal end of said means including a patient port, air supply port and an endotracheal tube; exhalation port, adapted to be connected to said air an air manifold having an inhalation port adapted to supply means and said endotracheal tube for pro communicate with said air supply means, a patient viding an air inhalation passageway between the port adapted to be connected to the proximal end patient port and said air supply port and for provid of said endotracheal tube and an exhalation port; ing an air exhalation passageway between said and patient port and said exhalation port; 45 a visual indicator in communication with said exhala means in communication with said exhalation port for tion port which changes color in the presence of providing a visual indication of the placement of carbon dioxide; wherein said visual indicator com the endotracheal tube in the trachea of the patient prises a cylindrical housing with air permeable end comprising a visual indicating material which caps for containing a chemical reagent which changes color in the presence of carbon dioxide; 50 changes color in the presence of carbon dioxide. and 17. An endotracheal intubation device as recited in a filter located between said visual indication means claim 16, wherein said visual indicator is integrally and said patient port to reduce inhalation of parti formed with said air manifold. cles from said visual indicating means. 18. An endotracheal intubation device as recited in 9. An endotracheal device as recited in claim 8, 55 claim 16, wherein said visual indicator is adapted to be wherein said filter is comprised of cotton, glass wool, or removably connected to said air manifold. filter paper. 19. An endotracheal intubation device as recited in 10. An endotracheal device as recited in claim 1, claim 16, wherein said visual indicator is adapted to be wherein said visual indicating means comprises a cylin regenerated. drical housing having a visual indicating material which 20. An endotracheal intubation device for verifying changes color when carbon dioxide is absorbed. the correct placement of an endotracheal tube in the 11. An endotracheal device as recited in claim 10, trachea of a patient comprising: further including removable caps for said cylindrical an endotracheal tube having a proximal end adapted housing for sealing the housing and preventing reaction to extend from the breathing passageway of a pa of the visual indicating material prior to patient use. 65 tient and a distal end adapted to extend into the 12. An endotracheal device as recited in claim 10, trachea of a patient; further including a removable airtight container for means for supplying air to the proximal end of said receiving said visual indicating means and preventing endotracheal tube; 4,790,327 13 14 an air manifold having an inhalation port adapted to an air manifold for providing an inhalation air pas communicate with said air supply means, a patient sageway between the resuscitator air bag and the port adapted to be connected to the proximal end endotracheal tube and for providing an exhalation of said endotracheal tube, and an exhalation port; air passageway between said endotracheal tube and and the atmosphere; and a visual indicator in communication with said exhala a visual indicator in communication with said exhala tion port which changes color in the presence of tion air passageway which indicates the presence carbon dioxide. of carbon dioxide; wherein said chemical reagent comprises a carbon wherein said air manifold includes a first tubular dioxide absorbing compound and a visual indicat 10 member, which defines a first air passageway hav ing material. ing an air supply port at one end and a patient port 21. The endotracheal intubation device as recited in at the other end, and a second tubular member claim 20, wherein the carbon dioxide absorbing com which is disposed intermediate the ends of said first pound is selected from the group consisting of the alkali tubular member so as to be in communication with metal hydroxide, alkaline earth hydroxide, alkaline 15 the air passageway of the first tubular member. earth oxide, amphoteric transition metal oxides and 31. An endotracheal intubation device as recited in combinations thereof. claim 30, wherein the longitudinal axis of said first tubu 22. An endotracheal intubation device as recited in lar member and said second tubular member are not claim 20, wherein the carbon dioxide absorbing com parallel. pound is selected from the group consisting of barium 20 32. An endotracheal intubation device as recited in oxide, barium hydroxide, calcium oxide, calcium hy claim 31, wherein the axis of said first tubular member droxide, sodium hydroxide, magnesium oxide, potas and the axis of said second tubular member are substan sium hydroxide, lithium hydroxide and combinations tially perpendicular. thereof. 33. An endotracheal intubation device as recited in 23. An endotracheal intubation device as recited in 25 claim 20, wherein the visual indicating material is se claim 30, wherein at least a portion of said second tubu lected from the group consisting of ethyl violet, thy lar member extends beyond the inner wall of said first malphthalein, alizarin yellow, phenolphthalein, thymol tubular member. blue, ethyl bis(2,4-dimethylphenol)acetate, p-naphthol 34. An endotracheal intubation device as recited in benzene, o-cresolphthalein and alizarin. 30 claim 30, further including an inhalation valve having a 24. A portable endotracheal intubation device for first operative position wherein the valve closes the verifying the correct placement of an endotracheal tube exhalation port opening of the second tube which ex in the trachea of a patient adapted to be connected tends into the first air passageway in response to air between an endotracheal tube and a resuscitator air bag flow in the direction from said air supply port to said comprising: 35 patient port and a second operative position which an air manifold for providing an inhalation air pas closes the air supply port in response to air flow in the sageway between the resuscitator air bag and the direction from the patient port to the exhalation port. endotracheal tube and for providing an exhalation 35. An endotracheal intubation device as recited in air passageway between said endotracheal tube and claim 30, further including an exhalation valve wherein the atmosphere, wherein said exhalation passage 40 the valve closes the exhalation port in response to air way is isolated from at least a portion of said air flow in the direction from the exhalation port to the passageway during exhalation; and patient port. a visual indicator in communication with said exhala 36. A portable endotracheal intubation device for tion air passageway which indicates the presence verifying the correct placement of an endotracheal tube of carbon dioxide. 45 in the trachea of a patient comprising: 25. An endotracheal intubation device as recited in a non-rebreathing valve having an air supply port, a claim 24, wherein said air manifold and said visual indi patient port adapted to be connected to a source of cator are formed as a one-piece assembly. air supply and an endotracheal tube, and an exhala 26. An endotracheal intubation device as recited in tion port which is isolated from said air supply port claim 25, further including means for preventing actua 50 during exhalation; and tion of said visual indicator prior to patient use. a visual indicator device in communication with said 27. An endotracheal intubation device as recited in exhalation port which changes color in the pres claim 26, further includes a removable airtight housing ence of carbon dioxide. adapted to receive said endotracheal intubation device 37. An endotracheal intubation device for verifying for preventing actuation of said visual indicator prior to 55 the correct placement of an endotracheal tube in the patient use. trachea of a patient comprising: 28. An endotracheal intubation device as recited in a non-rebreathing valve having an air supply port, a claim 24, wherein said manifold comprises two tubes patient port adapted to be connected to a source of connected together to form an inhalation air passage air supply and an endotracheal tube, and an exhala way and an inhalation air passageway. 60 tion port; and 29. An endotracheal intubation device as recited in a visual indicator device in communication with said claim 28, wherein at least a portion of said inhalation air exhalation port which changes color in the pres passageway is common with said exhalation air passage ence of carbon dioxide; way. wherein said indicator device comprises a hollow 30. An endotracheal intubation device for verifying 65 cylindrical member having air permeable end caps the correct placement of an endotracheal tube in the which define a chamber for receiving a chemical trachea of a patient adapted to be connected between an reagent which changes color in the presence of endotracheal tube and a resuscitator air bag comprising: carbon dioxide. 4,790,327 15 16 38. An endotracheal intubation device for verifying 39. An endotracheal device as recited in claim 38, the correct placement of an endotracheal tube in the further including a removable end cap adapted to close trachea of a patient comprising: the patient port, air supply port and the inhalation port to prevent actuation of the visual indicator device prior a non-rebreathing valve having an air supply port, a to patient use. patient port adapted to be connected to a source of 40. An endotracheal intubation device as recited in air supply and an endotracheal tube, and an exhala claim 36, wherein said visual indicator device is remov tion port; and able from said non-rebreathing valve. a visual indicator device in communication with said 41. An endotracheal intubation device as recited in exhalation port which changes color in the pres 10 claim 40, further including removable end caps for pre venting actuation of said indicator device prior to pa ence of carbon dioxide; tient use. wherein said non-rebreathing valve and said indicator 42. An endotracheal intubation device as recited in device are integrally formed such that said indica claim 40, wherein said visual indicator device is regen tor device is integrally coupled to said exhalation 15 erable and adapted to be reused after regeneration. port. is k it