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
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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 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
dominik.roth@meduniwien.ac.at

Contact information

Dr Dominik Roth
Scientific

Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Email	dominik.roth@meduniwien.ac.at

Study information

Study design	Single-center, randomised assessor-blinded controlled parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Please use the contact details below to request a patient 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	Absence of neuropsychological sequelae 1 month after intoxication
Secondary outcome measures	1. Time until COHb-level reaches 3% or less 2. Changes in neuropsychological sequelae between hospital discharge and 1 month after intoxication 3. Quality of life after 1 month 4. Mortality after 1 month 5. Adverse events 6. Length of Stay at ICU 7. Length of stay in hospital 8. Hospital admission within 1 month
Overall study start date	25/06/2014
Completion date	31/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Department of Emergency Medicine

Vienna
1090
Austria

Sponsor information

Medical University of Vienna
University/education

c/o Assoc. Prof. Dr. Christof Havel
Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Website	http://www.meduniwien.ac.at/homepage/1/homepage/
"ROR"	https://ror.org/05n3x4p02

Funders

Funder type

Research organisation

Austrian Association of Emergency and Disaster Medicine: Reinhard Malzer scientific fund (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/09/2020: No publications found.