Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers
PreOx-OHD
Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.
1 other identifier
interventional
50
1 country
1
Brief Summary
High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. However, its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement during preoxygenation before general anaesthesia. The goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face mask) and using high flow nasal canula oxygen, in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
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
January 2, 2018
CompletedFirst Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJanuary 16, 2018
January 1, 2018
3 months
January 8, 2018
January 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FeO2 at 3 min
end tidal oxygen fraction measured through a gas analyser
3 minutes
Secondary Outcomes (4)
time to obtain an FeO2 at 90%
6 minutes
proportion of adequate preoxygenation at 3 min
6 minutes
tolerance
1 hour
tolerance on VAS
1 hour
Study Arms (2)
control
ACTIVE COMPARATORspontaneous breathing through a face mask connected to the anaesthesia machine delivering 100% oxygen gas flow (15l/min)
ohd
EXPERIMENTALspontaneous breathing through a nasal cannula connected to an humidifier device delivering warm (37°C) high flow oxygen(60l/min)
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteers,
- signed contentment
You may not qualify if:
- any chronic or acute disease,
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Caen
Caen, 14033, France
Related Publications (1)
Hanouz JL, Lhermitte D, Gerard JL, Fischer MO. Comparison of pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen: A randomised controlled crossover study in healthy volunteers. Eur J Anaesthesiol. 2019 May;36(5):335-341. doi: 10.1097/EJA.0000000000000954.
PMID: 30664524DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 16, 2018
Study Start
January 2, 2018
Primary Completion
March 31, 2018
Study Completion
June 30, 2018
Last Updated
January 16, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share