Clinical trial NCT03399695: Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers
Official title: Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Airway Morbidity
Safety Issues
Keywords: preoxygenation
high flow oxygen
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* healthy volunteers,
* signed contentment

Exclusion Criteria:

* any chronic or acute disease,
* pregnancy

Primary outcomes:
measure: FeO2 at 3 min
timeFrame: 3 minutes
Secondary outcomes:
measure: time to obtain an FeO2 at 90%
timeFrame: 6 minutes
measure: proportion of adequate preoxygenation at 3 min
timeFrame: 6 minutes
measure: tolerance
timeFrame: 1 hour
measure: tolerance on VAS
timeFrame: 1 hour
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
References:
citation: 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.