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.

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Airway Morbidity; Safety Issues
• Intervention / Treatment: Procedure: preoxygenation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • University Hospital of Caen
    • Contact: jean-luc Hanouz, md, phd; Phone Number: +33 02 31 06 47 36; Email: hanouz-jl@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers,
• signed contentment

Exclusion Criteria:

• any chronic or acute disease,
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FeO2 at 3 min	end tidal oxygen fraction measured through a gas analyser	3 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2018
• Primary Completion (ANTICIPATED): March 31, 2018
• Study Completion (ANTICIPATED): June 30, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (ACTUAL): January 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: preoxygenation; high flow oxygen
• Other Study ID Numbers: ID RCB 2017-A02343-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No