Non-invasive CPAP-Ventilation versus Oxygen-therapy using a simple face mask for Carbon Monoxide poisoning
| ISRCTN | ISRCTN05226190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05226190 |
| Protocol serial number | N/A |
| Sponsor | Medical University of Vienna |
| Funder | Austrian Association of Emergency and Disaster Medicine: Reinhard Malzer scientific fund (Austria) |
- Submission date
- 12/06/2014
- Registration date
- 20/06/2014
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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 patientsÂ’ 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
dominik.roth@meduniwien.ac.at
Contact information
Scientific
Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
| dominik.roth@meduniwien.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center, randomised assessor-blinded controlled parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Non-invasive CPAP-ventilation versus oxygen-therapy using a simple face mask for carbon monoxide poisoning: A single-center, randomised assessor-blinded controlled parallel-group study |
| Study acronym | CO-CPAP |
| Study objectives | Non-invasive CPAP ventilation using a tight face mask reduces the incidence of neuropsychological sequelae 1 month after carbon monoxide intoxication compared to standard oxygen inhalation using a simple face mask with oxygen reservoir. |
| Ethics approval(s) | Medical University of Vienna Ethics Committee, 19/05/2011, ref. 251/2011 |
| Health condition(s) or problem(s) studied | Carbon monoxide poisoning |
| Intervention | Intervention: Non-invasive CPAP ventilation using a tight mask and standard respirator equipment Control: Oxygen inhalation therapy by a simple facemask with oxygen reservoir |
| Intervention type | Other |
| Primary outcome measure(s) |
Absence of neuropsychological sequelae 1 month after intoxication |
| Key secondary outcome measure(s) |
1. Time until COHb-level reaches 3% or less |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 74 |
| Key inclusion criteria | 1. Adult patients (i.e. at least 18 years old) treated at the Emergency Department 2. Elevated levels of COHb (COHb >= 7%) AND either assured CO-exposition (for example, faulty gas-heater, fire) or symptoms consistent with CO poisoning |
| Key exclusion criteria | 1. Patients being comatose on admission 2. Patients intubated by Emergency Medical Service 3. Patients requiring mechanical ventilation 4. Pregnant women |
| Date of first enrolment | 25/06/2014 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- Austria
Study participating centre
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2020: No publications found.
