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

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03399695

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Airway Morbidity Safety Issues	Procedure: preoxygenation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Mar 31, 2018

Anticipated Study Completion Date :

Jun 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

FeO2 at 3 min [3 minutes]
end tidal oxygen fraction measured through a gas analyser

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy volunteers,
signed contentment

Exclusion Criteria:

any chronic or acute disease,
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Caen	Caen		France	14033

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03399695

Other Study ID Numbers:

ID RCB 2017-A02343-50

First Posted:

Jan 16, 2018

Last Update Posted:

Jan 16, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Caen

preoxygenation

high flow oxygen

Study Results

No Results Posted as of Jan 16, 2018