Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers (PreOx-OHD)

Caen University Hospital

Status: Unknown

Conditions: Safety Issues; Airway Morbidity; Anesthesia

Treatments: Procedure: preoxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT03399695

ID RCB 2017-A02343-50

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers,
• signed contentment

Exclusion criteria

• any chronic or acute disease,
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control

Active Comparator group

Description:

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

Treatment:

Procedure: preoxygenation

ohd

Experimental group

Description:

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

Treatment:

Procedure: preoxygenation