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Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers

Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03399695
Acronym
PreOx-OHD
Enrollment
50
Registered
2018-01-16
Start date
2018-01-02
Completion date
2018-06-30
Last updated
2018-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity, Anesthesia, Safety Issues

Keywords

preoxygenation, high flow oxygen

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.

Detailed description

High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. The results suggest that high flow oxygen could be superior to bag reservoir face mask in term of occurrence of severe hypoxemia during the intubation procedure. At the present time 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 ensuring that the functional residual capacity has been filled with oxygen. We planned a randomised cross over study in healthy volunteers studying efficacy and tolerance of preoxygenation using spontaneous ventilation with 100% inhaled oxygen through a face mask connected to the anaesthesia machine and preoxygenation using high flow nasal cannula oxygen (60l/min).

Interventions

PROCEDUREpreoxygenation

spontaneous breathing

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy volunteers, * signed contentment

Exclusion criteria

* any chronic or acute disease, * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
FeO2 at 3 min3 minutesend tidal oxygen fraction measured through a gas analyser

Secondary

MeasureTime frameDescription
time to obtain an FeO2 at 90%6 minutestime to obtain an end tidal oxygen fraction measured at 90% measured through a gas analyser
proportion of adequate preoxygenation at 3 min6 minutesproportion of adequate preoxygenation (FeO2=90%) at 3 min
tolerance1 hourself reported tolerance on a likert scale
tolerance on VAS1 hourself reported tolerance on a visual analogue scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026