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

NCT ID: NCT03399695

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-06-30

Brief Summary

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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

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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).

Conditions

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Anesthesia Airway Morbidity Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

spontaneous breathing through a face mask connected to the anaesthesia machine delivering 100% oxygen gas flow (15l/min)

Group Type ACTIVE_COMPARATOR

preoxygenation

Intervention Type PROCEDURE

spontaneous breathing

ohd

spontaneous breathing through a nasal cannula connected to an humidifier device delivering warm (37°C) high flow oxygen(60l/min)

Group Type EXPERIMENTAL

preoxygenation

Intervention Type PROCEDURE

spontaneous breathing

Interventions

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preoxygenation

spontaneous breathing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers,
* signed contentment

Exclusion Criteria

* any chronic or acute disease,
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Caen

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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jean-luc Hanouz, md, phd

Role: primary

02 31 06 47 36 ext. +33

References

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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.

Reference Type DERIVED
PMID: 30664524 (View on PubMed)

Other Identifiers

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ID RCB 2017-A02343-50

Identifier Type: -

Identifier Source: org_study_id

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