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

Not Applicable

• Conditions: Airway Morbidity; Anesthesia; Safety Issues
• Interventions: Procedure: preoxygenation

• Registration Number: NCT03399695
• Lead Sponsor: University Hospital, Caen

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).

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-02
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Study First Posted: 2018-01-16
• Last Update Posted: 2018-01-16
• Primary Completion: 2018-03-31
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• healthy volunteers,
• signed contentment

Exclusion Criteria

• any chronic or acute disease,
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control	preoxygenation	spontaneous breathing through a face mask connected to the anaesthesia machine delivering 100% oxygen gas flow (15l/min)
ohd	preoxygenation	spontaneous breathing through a nasal cannula connected to an humidifier device delivering warm (37°C) high flow oxygen(60l/min)

Primary Outcome Measures

Name	Time	Method
FeO2 at 3 min	3 minutes	end tidal oxygen fraction measured through a gas analyser

Secondary Outcome Measures

Name	Time	Method
time to obtain an FeO2 at 90%	6 minutes	time to obtain an end tidal oxygen fraction measured at 90% measured through a gas analyser
proportion of adequate preoxygenation at 3 min	6 minutes	proportion of adequate preoxygenation (FeO2=90%) at 3 min
tolerance	1 hour	self reported tolerance on a likert scale
tolerance on VAS	1 hour	self reported tolerance on a visual analogue scale

Trial Locations

Locations (1)

University Hospital of Caen; 🇫🇷 Caen, France