Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B. Drinkwaard

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes