Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Dominik Roth
ORCID ID
Contact details
Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
-
dominik.roth@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
CO-CPAP
Study hypothesis
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
Medical University of Vienna Ethics Committee, 19/05/2011, ref. 251/2011
Study design
Single-center, randomised assessor-blinded controlled parallel-group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
25/06/2014
Overall trial end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
74
Participant exclusion criteria
1. Patients being comatose on admission
2. Patients intubated by Emergency Medical Service
3. Patients requiring mechanical ventilation
4. Pregnant women
Recruitment start date
25/06/2014
Recruitment end date
31/07/2015
Locations
Countries of recruitment
Austria
Trial participating centre
Department of Emergency Medicine
Vienna
1090
Austria
Sponsor information
Organisation
Medical University of Vienna
Sponsor details
c/o Assoc. Prof. Dr. Christof Havel
Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Austrian Association of Emergency and Disaster Medicine: Reinhard Malzer scientific fund (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list