Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR268; 0515
Study information
Scientific title
Acronym
Study hypothesis
The Oxylator® EMX is as effective as the bag-valve device in ventilating pre-hospital patients (blood oxygen saturation and carbon dioxide).
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, single-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mechanical ventilation need
Intervention
1. Mask ventilation with Oxylator® EMX or Bag-valve device
2. Measuring periferal saturation and end-tidal CO2 (ETCO2) with device
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measures
1. Periferal oxygen saturation
2. End tidal carbon dioxide (CO2)
Secondary outcome measures
1. Survival to hospital
2. Hospital O2 saturation and ETCO2
3. Hospital blood gas
Overall trial start date
02/05/2005
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Emergency Medical Services (EMS) patients aged greater than 18 years requiring mask ventilation.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Cardiac arrest
2. Pregnancy
Recruitment start date
02/05/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
St. Elisabeth Hospital
Tilburg
5000 LC
Netherlands
Sponsor information
Organisation
CPR Medical Devices Inc. (Canada)
Sponsor details
20 Summerhill Gardens
Toronto
Ontario
M4T 1B4
Canada
+1 416 691 2669
haro@crpmedic.com
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
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
Results - basic reporting
Publication summary