Assessment of Preoxygenation Strategies in the Prehospital Environment
1 other identifier
interventional
30
1 country
1
Brief Summary
Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 30, 2016
September 1, 2016
5 months
February 24, 2016
September 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fractional Expired Oxygen Concentration
Measure of denitrogenation efficacy
3 minutes
Secondary Outcomes (1)
Ease of breathing assessment using a visual analogue scale
3 minutes
Study Arms (3)
CPAP
EXPERIMENTAL3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.
BVM
EXPERIMENTAL3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.
NRM
EXPERIMENTAL3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.
Interventions
CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
Eligibility Criteria
You may qualify if:
- Adult volunteers
You may not qualify if:
- Pregnancy
- Respiratory disease
- Bearded
- Facial abnormality
- Edentulous
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen Mary University of Londonlead
- Essex and Herts Air Ambulancecollaborator
Study Sites (1)
Essex & Herts Air Ambulance Trust
Earls Colne, Essex, CO6 2NS, United Kingdom
Related Publications (1)
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.
PMID: 26728311BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J Groombridge, MBBS
Queen Mary University of London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 24, 2016
First Posted
February 29, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 30, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share