Assessment of Preoxygenation Strategies in the Prehospital Environment
NCT ID: NCT02694705
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-02-29
2016-07-31
Brief Summary
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Detailed Description
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Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.
The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:
1. Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
2. Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
3. Non-rebreather mask (NRM) device with 15 l/min oxygen flow.
Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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CPAP
3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
Continuous Positive Airway Pressure (CPAP)
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
BVM
3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.
Bag-Valve-Mask (BVM)
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
NRM
3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
Non-rebreather Mask (NRM)
Preoxygenation provided by NRM, oxygen flow rate 15 l/min
Interventions
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Continuous Positive Airway Pressure (CPAP)
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
Bag-Valve-Mask (BVM)
Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
Non-rebreather Mask (NRM)
Preoxygenation provided by NRM, oxygen flow rate 15 l/min
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Respiratory disease
* Bearded
* Facial abnormality
* Edentulous
18 Years
ALL
Yes
Sponsors
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Essex and Herts Air Ambulance
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Christopher Groombridge
Dr
Principal Investigators
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Christopher J Groombridge, MBBS
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
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Essex & Herts Air Ambulance Trust
Earls Colne, Essex, United Kingdom
Countries
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References
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Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.
Other Identifiers
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QMERC2015/69
Identifier Type: -
Identifier Source: org_study_id