CAROTID ARTERY DOPPLER - ACHOBEL



CAROTID ARTERY DOPPLER

A Prospective Study of the Risk for Decompression Sickness

in Divers with Right-to-Left Shunts

Dear Fellow-Diver,

Thank you for participating in this exciting new study, aimed at providing a definite answer to a question that many diving doctors, and even more important, many divers, have : “What exactly is the risk of decompression sickness (DCS) while diving when you have been diagnosed as having a Patent Foramen Ovale (PFO)?”

To answer this question, there is only one way : almost 4000 divers have to be “screened” for possible right-to-left cardiac shunts, and then be followed up for approximately 5 years. All episodes of decompression sickness need to be recorded during that period, and only then can be determined if divers have indeed an important risk for DCS when they have a PFO. By consenting in taking part in this study, you are a key factor in diving safety research.

Taking part in this study is simple, safe, and will cause only minimal discomfort to you. However, you are free to choose not to take part. In that case, just tell the examining doctor that you do not want to participate in the study.

When you agree to participate, the examining doctor will perform a “Carotid Artery Doppler” test on you. This involves the placement of an infusion catheter in a forearm vein, and the injection of an “agitated” standard physiologic saline solution by means of a syringe. This saline “contrast medium” will be monitored at the level of the carotid artery, by the examiners assistant, using a vascular ultrasound device. The whole procedure takes about 20 minutes, and is without any danger to you. In fact, thousands of cardiac patients undergo this same procedure during echocardiography every day. Since a minuscule quantity of air is used to mix the saline, however, it is important that you have not dived in the previous 24 hours. Also, for extra security, oxygen is available in case you should feel drowsy after the test. Normally, this will not happen.

In order to guarantee the scientific value of this study, it is important to know that the result of this first test will only be communicated to you after the study period (5 years). During this period, you should not change your safe diving habits depending on the result of this first test ! Rest assured, the current scientific knowledge on PFO and diving indicates that even divers with a right-to-left shunt can dive safely, if they follow the simple rules of safety of recreational diving. Furthermore, this test is a “screening” test, which means it does not have the precision of a diagnostic test.

You will then receive a study package, containing some information about the Divers Alert Network, safe diving and the current research going on. This package also contains a « report card » with the telephone and fax number that you will have to contact in case of having had a decompression sickness episode. This information is of vital importance to the study, so please do not loose the card !

Legally, we are obliged to have you sign this “consent form”. If you need any more information before signing the form, please don’t hesitate to ask.

I who sign (please print full name) ………………………………………………………………..…

Have been explained and understand the study I am taking part in, and consent take part in it and to undergo the Carotid Artery Doppler test that is the initial evaluation of the study.

(please write : “read and approved”) ………………………………..……………………………

(and sign :) ……………………………….. Date : …………….. Place : ……………

This page will be kept with the records of the examiner.

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