INFORMED CONSENT INFORMATION ADDRESSOGRAPH DATA

BRONCHOSCOPY WITH OR WITHOUT

You have decided to have an important procedure and we appreciate your selection of UCLA Healthcare to meet your needs. It is important to you and to us that you fully understand the risks, benefits and alternatives to the procedure you have planned. The purpose of this document is to provide written information regarding the risks, benefits and alternatives to this procedure. The information provided here is a supplement to the discussions you have had with your surgeon(s) in preparation for the procedure. You should read this material and ask your surgeon(s) any questions you have before giving your consent.

The Procedure: You have a condition that requires visualization (bronchoscopy) and possible sampling (biopsy) of your airway. This is performed in the evaluation of cancers, infections, and other respiratory diseases. During the procedure, a flexible (and/or in certain circumstances, a rigid) tube with a light and video camera (bronchoscope) is inserted into your throat either through the mouth or nose and is used to evaluate the inside of your airway from your down into each . Your surgeon(s) may find it necessary and prudent to obtain a biopsy, which is done with a miniature device specifically made to take a small sample from the inside of the airway. The procedure can last from a few minutes to as long as 1-2 hours, depending on the individual patient’s circumstances. The procedure often can be accomplished under local (with or without intravenous sedation) but in selected conditions general anesthesia may be necessary.

Benefits Some benefits that may be gained from might not be detected by any other undergoing bronchoscopy are listed test(s) and/or x-ray(s). below. Your physician cannot guarantee 2. Bronchoscopy with biopsy may you will receive any of these benefits. establish a diagnosis, which could Only you can decide if the benefits are substantially change your future worth the associated risk(s). treatment and prognosis. 3. Bronchoscopy with biopsy, in unusual 1. Bronchoscopy with or without a biopsy cases, may improve airflow into and may yield important information about out of the by removing established and/or new (unsuspected) obstructing tissue/material, resulting in diseases involving your airway which 6/5/03 1

better breathing following the procedure.

Risks Before undergoing this procedure, a arranged to have your own blood thorough understanding of the associated stored ahead of time and available for risks is essential. The following risks are the procedure, the use of blood from well recognized, but there may be other designated or anonymous donors risks not included in this list that are could be necessary. If you receive this unforeseen by your surgeon(s): type of blood, you could develop fevers (1 in 100), an allergic reaction 1. Bleeding in the airway may occur (1 in 100), red blood cell destruction or during or following the procedure. The “hemolytic reaction” (1 in 6000), chance of bleeding increases if a hepatitis B (1 in 50,000), hepatitis C (1 biopsy is performed. Although any in 100,000), human immunodeficiency bleeding that may occur generally viral infection or “HIV” (1 in 500,000), amounts to only a few teaspoons of other blood-borne infection, ie., blood, even a small amount of blood in syphilis, malaria, Chagas’ disease, the airway can potentially lead to other viruses, etc. (1 in 1000), or a blockage, breathing difficulty, and severe/fatal acute or allergic reaction (rarely) death. If bleeding does occur, (1 in 100,000). the blood is normally suctioned from 3. Infections may develop following your airway until all bleeding stops; bronchoscopy regardless of whether a however, you will likely biopsy was performed. Possible (expectorate) bloody phlegm for a few infections include an infection of the days or up to two weeks following the major airways (bronchitis) and an procedure. Bleeding is made worse by infection of the lung itself (pneumonia). taking aspirin, certain anti- Infections at insertion sites of inflammatory medications (NSAID’s, intravenous catheters (i.v.’s) also ie, Advil, Aleve, Vioxx, etc.), and blood occur. Rarely, sinus infections can thinners (ie, coumadin, heparin, etc.). occur if the bronchoscope is passed Generally, these medications should through the nose. These infections be stopped for a week prior to the usually are accompanied by fevers procedure. If you are taking any of and either a cough productive of these medications, please inform your yellowish or green phlegm or pain, physician. redness, and possibly drainage at the 2. If you have a bleeding problem, have site of a intravenous catheter. The been on blood thinners treatment of these infections is (anticoagulants), or have an anemia antibiotics with or without (low red blood cell count), it may be expectorants. With treatment necessary in rare cases to give you a essentially all infections can be cured. blood transfusion. If you require 4. Breathing difficulty with or without a blood transfusion and have not low blood oxygen level may develop

during or following bronchoscopy. This 6. Leakage of air from the lung into its does not occur very frequently but is surrounding sack with collapse of the more likely if you have a pre-existing lung () occurs rarely breathing problem, ie., , during or shortly following the emphysema, “COPD”, etc. You could procedure. This usually occurs experience wheezing and/or chest following a biopsy. Many people have tightness. During the procedure you no symptoms and the pneumothorax will be given additional oxygen to is detected only by an x-ray, but some breathe, and in simple cases, patients develop mild to severe medications to help your breathing , particularly if may be administered. If you develop there is a pre-existing lung problem. A serious breathing difficulty, however, it small pneumothorax can be observed may become necessary to place a and may need no treatment, but larger breathing (endotracheal) tube into pneumothoraces and those associated your airway to assist your breathing. with shortness of breath require a This could require hospital admission small tube to be placed through the and the use of a mechanical ventilator. skin into the chest to remove the air. 5. Abnormal heart beats (arrhythmias) This sometimes requires a hospital can occur during almost any admission. procedure done on the chest but are 7. Medication reactions occur only rare during bronchoscopy. You are rarely during or following more likely to develop arrhythmias if bronchoscopy. The medications you have had one previously or have commonly used are widely available significant heart problems. If they do and include lidocaine (similar to dental occur, you may experience novocain), demerol or other - palpitations and could require like drugs, or Versed medication to stop or control the (similar to Valium), and abnormal heart beats. Most metaproterenol or similar agent to arrhythmias that occur are easily dilate bronchial airways. If you have treated, are temporary (lasting only an allergy to any one of these or minutes to hours), and are not similar types of medications, please necessarily an indication of a serious inform your surgeon(s) prior to the underlying heart problem. In rare procedure. If a reaction occurs, you circumstances, arrhythmias can lead could develop a rash, swelling, nausea to low requiring the and/or vomiting, an unusual feeling, brief application of an amount of and even wheezing and/or shortness electrical energy to the heart of breath. A reaction is treated by (cardioversion) to stop it. If you have stopping any and all offending severe heart disease, a heart attack or medications, and, if necessary, by stroke also could occur during or giving you other medications to control immediately following the procedure, your symptom(s). although this is rare. 8. Discomfort may occur during and following the procedure. Local (topical)

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anesthesia with intravenous sedation analgesics, such as acetaminophen or, in some cases, general anesthesia (Tylenol). If you have had a biopsy, is used to minimize any discomfort you should not use aspirin, anti- during the procedure. You are inflammatory medications (NSAID’s, encouraged to communicate any ie, Advil, Aleve, Vioxx, etc.), or blood discomfort that you might have during thinners (ie, coumadin, heparin, etc.). the procedure to your surgeon(s). unless specifically approved by your Following the procedure, you may surgeon(s). experience slight throat discomfort 9. Death. Life-threatening complications with or without a dry cough and even leading to death following hoarseness for one or more days. This bronchoscopy are extremely rare is normal and usually is easily (<0.01%). controlled by over-the-counter

Alternatives The alternatives to bronchoscopy include 2. Close medical observation can be the following limited options: used to assess airway problems and their developments over time without 1. Radiologic evaluation of the airways invasive procedures, however, the can be accomplished with computed main risk of this approach is tomography (CT or “CAT”) and MRI irreversible progression of disease, ie., (“MR”) scans. These scans, however, spread of cancer, lung scarring can not detect small abnormalities and (pulmonary fibrosis), airway also cannot be used to obtain a biopsy destruction (), etc., of the central airways. Abnormalities at leading to permanent respiratory the edge of the lung can be biopsied disability and/or death. with small needles guided by these If you decide not to have this procedure, scans, but the risks are essentially the there may be associated risks to this same and may even exceed those of decision. Please discuss it with your bronchoscopy. doctor.

I discussed the above risks, benefits, and alternatives with the patient. The patient had an opportunity to have all questions answered and was given a copy of this information sheet.

Physician Signature Date

Patient Signature Date

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