A randomised clinical trial of the effectiveness of ventilation by Oxylator® EMX versus bag-valve device in pre-hospital emergency patients
| ISRCTN | ISRCTN20664878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20664878 |
| Secondary identifying numbers | NTR268; 0515 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B. Drinkwaard
Scientific
Scientific
St. Elisabeth Hospital
P.O. Box 90151
Tilburg
5000 LC
Netherlands
Study information
| Study design | Randomised, single-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The Oxylator® EMX is as effective as the bag-valve device in ventilating pre-hospital patients (blood oxygen saturation and carbon dioxide). |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 02/05/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Emergency Medical Services (EMS) patients aged greater than 18 years requiring mask ventilation. |
| Key exclusion criteria | 1. Cardiac arrest 2. Pregnancy |
| Date of first enrolment | 02/05/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St. Elisabeth Hospital
Tilburg
5000 LC
Netherlands
5000 LC
Netherlands
Sponsor information
CPR Medical Devices Inc. (Canada)
Industry
Industry
20 Summerhill Gardens
Toronto, Ontario
M4T 1B4
Canada
| Phone | +1 416 691 2669 |
|---|---|
| haro@crpmedic.com |
Funders
Funder type
Not defined
Not provided at time of registration
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 |
