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Preliminary Development and Engineering Evaluation of a Novel Jason P Preliminary Development and Engineering Evaluation of a Novel Jason P. Carey1 e-mail: [email protected] Cricothyrotomy Device Morgan Gwin Cricothyrotomy is one of the procedures used to ventilate patients with upper airway Andrew Kan blockage. This paper examines the most regularly used and preferred cricothyrotomy devices on the market, suggests critical design specifications for improving cricothyro- Roger Toogood tomy devices, introduces a new cricothyrotomy device, and performs an engineering evaluation of the device’s critical components. Through a review of literature, manufac- turer products, and patents, four principal cricothyrotomy devices currently in clinical Department of Mechanical Engineering, Downloaded from http://asmedigitalcollection.asme.org/medicaldevices/article-pdf/4/3/031009/5678925/031009_1.pdf by guest on 24 September 2021 University of Alberta, Edmonton, AL, T6G 2G8, use were identified. From the review, the Cook™ Melker device is the preferred method of Canada clinicians but the device has acknowledged problems. A new emergency needle cricothy- rotomy device (ENCD) was developed to address all design specifications identified in literature. Engineering, theoretical, and experimental assessments were performed. In Barry Finegan situ evaluations of a prototype of the new device using porcine specimens to assess Department of Anesthesiology and Pain insertion, extraction, and cyclic force capabilities were performed. The device was very Medicine, successful in its evaluation. Further discussion focuses on these aspects and a compari- University of Alberta, son of the new device with established devices. The proposed emergency needle crico- 8-120 Clinical Sciences Building, thyrotomy device performed very well. Further work will be pursued in the future with Edmonton, AB, Canada, T6G 2G3 in-vitro and in-vivo with canine models demonstrates the capabilities of the ENCD. ͓DOI: 10.1115/1.4002237͔ Keywords: airway obstruction, cricothyrotomy, device review, engineering analysis and evaluation, in situ force testing 1 Introduction multiple steps. In contrast, although relatively simple to insert, needle cricothyrotomy devices used in high pressure jet ventila- It is estimated that over 3000 upper airway obstructed patients tion systems are frequently difficult to fixate and maintain at- die each year in the United States due to the inability to achieve tached during the ventilation process ͓4͔. On the other hand, jet sufficient airway exchange ͓1͔. Upper airway obstruction often ventilation systems are advantageous in that they have the ability afflicts trauma patients. Emergency ventilation procedures are of- to supply 25 l/min of oxygen and can be more effective than low ten performed by first responders with the primary objective of pressure systems in providing adequate volumes of air to the pa- reaching hospital emergency care units with live patients. Venti- tient ͓5͔. In comparison, under optimal circumstances, a low pres- lating these patients provides time for emergency clinicians to sure ventilation system can only reach 3–5 l/min of air, which may address other life-threatening conditions and is thus a critical as- not be enough to provide adequate ventilation ͓5͔. pect of saving trauma patients. Notwithstanding these limitations, an emergency needle crico- Jet- or bag-based ventilations have been used successfully as an thyrotomy device ͑ENCD͒ is an effective option to secure the effective means to ventilate a patient with upper airway distress. human airway, particularly in children, when other noninvasive One procedure used to provide an entryway for such ventilation is methods fail ͓6͔. A report from the Canadian Military Medical cricothyrotomy. A cricothyrotomy is performed by inserting a personnel emphasizes the importance and impact of emergency needle into the trachea via the cricothyroid membrane, where ven- cricothyrotomy procedures on the ground. Using a single patient tilation is provided by either low pressure ventilation ͑at ambient case study, they stress the significance of the procedure and imply atmospheric pressure, achieved by a hand pump͒ or with high that a simpler cricothyrotomy device and procedure could have a pressure jet systems ͑at ϳ400 kPa ͑50 psi͒͒ ͓2͔. While treatment significant impact on the number of these procedures being per- may depend on the severity of the injury, treatment procedures formed ͓7͔ and thus, increase the potential of saving Canadian or have not been standardized ͓3͔. Some of the known complications other military personnel. This can easily be applied to emergency of the procedure are as follows: ͑a͒ airway trauma due to incorrect care of trauma patients in motor vehicle or work-related accidents. directionality of air, which if not directed toward the lungs may force out the tube or cause additional trauma to the airway wall 1.1 Existing Devices. Current state-of-the-art equipment used and fill lungs with blood; ͑b͒ tube slipping out during treatment or to perform ventilation cricothyrotomy is often little more than a patient motion/struggle; ͑c͒ tube insertion difficulty after airway modified catheter inserted after making an incision in the crico- puncture; ͑d͒ airway wall trauma caused by the needle or due to thyroid membrane. Brofeldt’s four step method ͑BFSM͓͒8͔ is a the tube whipping during the air burst; and ͑e͒ pulmonary simplified procedure that can be completed in less than 30 s and barotrauma due to excessive generation of airway pressure ͑par- only requires a No. 20 scalpel, a tracheal hook with a large radius, ticularly if high pressure jet ventilation is employed͒. and a cuffed tracheostomy tube. The majority of currently available devices use low pressure A variation of this method involves inserting an endotracheal ventilation methods and typically the insertion process involves tube by using a modified BFSM procedure as proposed in the work of Bair and Sakles ͓9͔. However, the process is complicated and requires extensive knowledge of anatomy ͓8͔. Training emer- 11Corresponding author. Manuscript received February 24, 2010; final manuscript received July 14, 2010; gency responders to do this procedure in ideal conditions may published online September 9, 2010. Assoc. Editor: Danny Bluestein. already be difficult, let alone performing the cricothyrotomy dur- Journal of Medical Devices Copyright © 2010 by ASME SEPTEMBER 2010, Vol. 4 / 031009-1 Table 1 The list of current cricothyrotomy devices Device Company Advantage Disadvantage Quicktrach/Manujet ͓4,5͔ VBM Medical Less than 1 min attachment Neck tape is unreliable in time, one step protocol anchoring the device to patient Melker ͓5͔ Cook Medical Currently the most used Five step protocol take device on the market s longer than 1 min to complete Nu Trake® ͓9,11,12͔ Armstrong Medical No advantages in comparison Does not provide fast, safe, to Quicktrach and Melker and secure airway to the patient Mini Trach ͓9,11,12͔ Smith Medical No advantages in comparison Does not provide fast, safe, to Quicktrach and Melker and secure airway to the patient Downloaded from http://asmedigitalcollection.asme.org/medicaldevices/article-pdf/4/3/031009/5678925/031009_1.pdf by guest on 24 September 2021 ing transportation of the patient to the emergency room ͑ER͒. ͑i͒ be capable of allowing proper airflow The Melker cannular cricothyrotomy kit, introduced by Cook ͑ii͒ be an accurate means of injecting air toward the lungs to Medical ͑Cook, Bloomington, IN͓͒10͔, offers a low pressure ven- minimize the risk of trauma caused by possible high pres- tilation system. As the procedure requires five steps, it is not the sure air flow impinging on the back wall of the airway most time efficient approach in providing ventilation to the patient ͑iii͒ have a minimal number of parts to assemble at the time of under emergency circumstances. One study found the Melker sys- use ͓ ͔ tem can require more than 1 min to install 5 , which could impact ͑iv͒ be simple to insert to minimize the time of insertion for the patient’s odds of survival. Despite the time consuming multi- emergency respondents step protocol and low air volume capabilities cited in literature, it ͑v͒ be simple to remove to allow hospital staff to proceed to a has prevailed as the most successful and effective cricothyrotomy different procedure quickly device on the market. ͑vi͒ cause little local trauma during insertion or extraction VBM Medical introduced the Quicktrach and Manujet ͑jet ven- ͑vii͒ indicate the insertion length to minimize the risk of over tilator͒ to address the jet ventilation limitations. The Quicktrach is a device that is sold as a single operating unit capable of intro- inserting the device, causing trauma to the airway ͑ ͒ ducing air in an airway by inserting the Quicktrach catheter in the viii have the ability to be used with current upper airway punc- airway through an incision in the cricothyroid membrane. The ture needle systems to minimize the number of nonstand- device is secured with neck tape and can be used with either a low ard parts, thus, increasing versatility and lowering cost of pressure ventilator or a high pressure jet ventilator ͑Manujet͒ sys- the device tem. This system is advantageous in that it requires less than 1 ͑ix͒ be adaptable to both jet ventilation and bag mask inhala- min for attachment and involves a single step procedure, which tion methods for increased versatility of the device can be critical under emergency scenarios ͓5͔. At the same time, ͑x͒ be self-anchoring, using a quickly implemented and reli- some of the major shortcomings of this product include the unre- able positive fixation system that would allow hands-off liable neck affixing approach ͑neck tape͒ and the short cannula, operation once installed which can be difficult to attach to some patients due to neck, face, or head trauma. It was also found that the device cannot ad- A device that would meet all these specifications would be the equately withstand the high pressure jet ventilation ͓4͔. only device of its kind on the market. Other devices include the Nu Trake® by Armstrong Medical The objective of this paper is to introduce a new emergency and the Mini Trach by Smith Medical.
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