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

Anesthesia Clinical Trial

— PreOx-OHD  

Official title:

Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399695
• Other study ID #: ID RCB 2017-A02343-50
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2018
• Last updated: January 8, 2018
• Start date: January 2, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteers,

• signed contentment

Exclusion Criteria:

• any chronic or acute disease,

• pregnancy

Related Conditions & MeSH terms

• Airway Morbidity
• Anesthesia
• Safety Issues

Intervention

Procedure:
• preoxygenation
spontaneous breathing

Locations

Country	Name	City	State
France	University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FeO2 at 3 min	end tidal oxygen fraction measured through a gas analyser	3 minutes
Secondary	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
Secondary	proportion of adequate preoxygenation at 3 min	proportion of adequate preoxygenation (FeO2=90%) at 3 min	6 minutes
Secondary	tolerance	self reported tolerance on a likert scale	1 hour
Secondary	tolerance on VAS	self reported tolerance on a visual analogue scale	1 hour