Informed Consent North Carolina

CLARIFICATION, UNDERSTANDING AND INFORMED CONSENT
TERM, PRE AND POST EXAM GUIDELINES FOR RESPIRATORY ENDOSCOPY

FOR USE IN HOSPITAL ALEMÃO OSWALDO CRUZ

1. What is it?

The procedure is performed to examine the airways, through the introduction of a flexible device through the nose or tracheostomy. This device has a micro-camera with an optical fiber system that lights the inside of the airways and provides the full view. Thus, the exam aids in the diagnosis of respiratory tract diseases, through biopsies, avage collection, monitoring of treatment and also in removing lesions.

2. How is it done?

Preparation requires fasting for 8 hours, including liquids (water included). The exam is performed with the patient lying on a stretcher. So that the patient experiences no discomfort during the procedure, such as choking and nausea, sedation is usually performed by intravenous injection of the appropriate drugs. Due to the administration of sedatives, the patient must be accompanyed by an adult for the exam. Anesthetics are also applied in the form of anesthetic spray, jelly and liquid, whose effect persists for about 45 to 60 minutes after the exam. During this time, you should avoid ingesting food or fluids to prevent choking. When biopsy is required, tweezers are passed through the bronchoscope in order to remove tissue fragments. If necessary, there will also be collection of pulmonary secretions, which will be sent to a pathologist and/or clinical laboratory for analysis. Remember that biopsies can be performed for various reasons, such as inflammation or removal of polyps, and do not necessarily mean suspected cancer. The physician in charge of the test will provide guidance and suspend daily use medication when needed. This procedure is performed in the Endoscopy Center and, after the exam, the patient remains under observation in the Endoscopy Ward (and is discharged after a few hours).

3. What are the main risks?

Complications associated with intravenous sedation are rare, and their solution is usually immediate, since it is performed by a physician. Complications are rare, but there may be:

• Phlebitis (inflammation at the site of drug application)

• Chest pain

• Nausea and vomiting

• Respiratory depression

• Sleepiness

• In 2% of cases, perforation can occur (such as pneumothorax and bleeding), requiring hospitalization and possible surgery, if necessary

Warning signs to watch for:

Bleeding (cough with bleeding)

• Temperature higher than 38 ° C

Delayed bleeding is rare and can manifest itself with local pain and signs of low blood pressure (such as fainting and dizziness when standing).

4. Care during the first 12 hours after procedure

a. There are no dietary restrictions after the exam.

b. Drinking alcoholic beverages should be avoided.

c. There are restrictions to physical activity.

d. You can not drive or work on the day of the exam. If necessary, request a medical certificate.

e. If chest pain is experienced after the procedure, the patient should seek the emergency service to perform chest X-ray assessing the possibility of pneumothorax.

f. The use of anticoagulants should be examined on a case-by-case basis, by the attending physician and the endoscopist physician.

• If there is suspicion of any complications, call the Endoscopy Center, seek emergency treatment at the Hospital, contact the doctor who performed the procedure and call your attending physician.

5. How to get the results?

The test results will be delivered by the Hospital Alemão Oswaldo Cruz Reports Center. In order to be properly interpreted, the test results should be related to several other data that your physician has access to. Thus, any doubt about the outcome of endoscopic test should be clarified with the physician who requested it.

6. Informed consent:

I was duly clarified and informed regarding the foreseeable risks, unexpected complications and after-procedure care, having fully understood all matters, and consent to the procedure for the patient: as well as to the filming / photographing and, if necessary, the publishing of these images for scientific purposes, ensuring full confidentiality of patient identity.

7. Accompanying adult Statement of Commitment:

I , holder of ID card number , am responsible for monitoring the patient after discharge from the endoscopic exam, according to the guidelines of the medical staff. I declare that I have received the aftertest guidelines in writing, and that I have fully understood them.

8. Medical Information:

I have explained clearly and objectively the entire procedure, exam, treatment and/or surgery the aforementioned patient is to undergo, to the patient him/herself and/or their guardian, in addition to informing them about the benefits, risks and alternatives, having answered their questions. It is my understanding that patient and/or his/ her guardian is able to understand what they were told.