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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03399695
Other study ID # ID RCB 2017-A02343-50
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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