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A Randomized Clinical Trial of the Effectiveness of Ventilation by Oxylator EMX versus Bag-Valve Device in pre-hospital emergency patients.


- candidate number1461
- NTR NumberNTR268
- ISRCTNISRCTN20664878
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDs0515 
- Public TitleA Randomized Clinical Trial of the Effectiveness of Ventilation by Oxylator EMX versus Bag-Valve Device in pre-hospital emergency patients.
- Scientific TitleA Randomized Clinical Trial of the Effectiveness of Ventilation by Oxylator EMX versus Bag-Valve Device in pre-hospital emergency patients.
- ACRONYMOxylator, respiratory failure, bag-valve device, prehospital
- hypothesisThe Oxylator EMX is as effective as the Bag-Valve device in ventilating prehospital patients (bloodoxygen saturation and carbon dioxide).
- Healt Condition(s) or Problem(s) studiedMask ventilation
- Inclusion criteriaEMS patients age > 18y requiring mask ventilation.
- Exclusion criteria1. Cardiac arrest;
2. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-mei-2005
- planned closingdate31-dec-2006
- Target number of participants200
- Interventions1. Mask ventilation with Oxylator EMX or Bag-valve device;
2. Measuring periferal saturation and end-tidal CO2 with device.
- Primary outcome1. Periferal oxygen saturation;
2. End tidal carbon dioxide (CO2).
- Secondary outcome1. Survival to hospital;
2. Hospital O2 saturation & ETCO2;
3. Hospital Bloodgas.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. B. Drinkwaard
- CONTACT for SCIENTIFIC QUERIESMD. F. Rutten
- Sponsor/Initiator CPR Medical Devices Inc
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryThis randomised clinical trial compares the efficacy of a handheld pressure regulated ventilator (Oxylator EMX) to the bag-valve device on prehospital EMS patients that require mask ventilation.
- Main changes (audit trail)
- RECORD8-sep-2005 - 14-sep-2009


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