Extrait

Background and study aims: Carbon monoxide (CO) is a leading cause of poisoning. There are 40,000 to 50,000 reported cases in the United States per year. It is assumed, however, that many more cases go unreported as it is difficult to diagnose. This is due to the nonspecific symptoms (for example, nausea, feeling tired and confused, vomiting, stomach pains and difficulty breathing) than can be similar to food poisoning or flu. CO poisoning not only leads to a number of acute symptoms but also to chronic complaints weeks or even months after the actual poisoning has taken place, the so called "neuropsychiatric sequelae". These symptoms can include headaches, nausea, lethargy, confusion, emotional lability, amnesia, and even psychosis. Current standard treatment of CO poisoning consists of inhaling oxygen via a simple face mask. The aim of this study is to test whether supporting the patients’ own breathing using a tight face mask and a ventilation machine (respirator) reduces the occurrence of those "neuropsychiatric sequelae". Who can participate? Patients treated for acute CO poisoning can be included in the study if the level of CO measured in their blood ("COHb") was at least 7% and they are at least 18 years old, not pregnant and that there was no need to insert a special tube to facilitate ventilation into their trachea ("intubation") What does this study involve? Patients are randomly assigned to either standard therapy (oxygen inhalation via a simple face mask) or study therapy (tight face mask and ventilation machine). During therapy CO-levels are continuously measured. Therapy will be stopped when CO-levels reach 3% or below. After completion of the therapy, a neuropsychiatric test will be performed. Patients will be contacted one month later to perform the test again, and will be asked about their quality of life. What are the possible benefits and risks of participating? All participants receive close monitoring and follow-up of their symptoms and quality of life. If the study hypothesis proves to be true, patients in the intervention group (those that were treated with study therapy) receive a better treatment with the potential to reduce later complaints. There are no anticipated risks from participation, however the face mask may feel uncomfortable for some patients. Where is the study run from? The study is run by the Department of Emergency Medicine of the Medical University of Vienna (Austria) When is the study starting and how long is it expected to run for? June 2014 to July 2015 Who is funding the study? Austrian Association of Emergency and Disaster Medicine (Austria) Who is the main contact? Dr. Dominik Roth [email protected]

Critère d'inclusion

• Carbon monoxide poisoning

Liens

• isrctn
• ictrp