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
Protocol serial number	NTR268; 0515
Sponsor	CPR Medical Devices Inc. (Canada)
Funder	Not provided at time of registration

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

Dr B. Drinkwaard
Scientific

St. Elisabeth Hospital
P.O. Box 90151
Tilburg
5000 LC
Netherlands

Primary study design	Interventional
Study design	Randomised, single-blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Periferal oxygen saturation 2. End tidal carbon dioxide (CO2)
Key secondary outcome measure(s)	1. Survival to hospital 2. Hospital O2 saturation and ETCO2 3. Hospital blood gas
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

St. Elisabeth Hospital

Tilburg
5000 LC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan