Skip to main content
Clinical Trials/NCT04814628
NCT04814628
Completed
Not Applicable

Contribution of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) to Optimize Maternal Pre-oxygenation and Anaesthetic Preparation Time for General Anaesthesia for Urgent Caesarean Section A Prospective Experimental Study on Healthy Volunteers.

Hospices Civils de Lyon1 site in 1 country1 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section Complications
Sponsor
Hospices Civils de Lyon
Enrollment
1
Locations
1
Primary Endpoint
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation
Status
Completed
Last Updated
last year

Overview

Brief Summary

The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
June 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • affiliated to a social security scheme or beneficiary of such a scheme
  • having voluntarily and informedly agreed to participate in the study.
  • non-smoker
  • free from pulmonary, cardiac and neurological pathologies
  • have a normal functional respiratory test at baseline.

Exclusion Criteria

  • refusal to participate in the study
  • non-French speaking volunteer
  • obesity defined by a body mass index greater than 30 kilogram/meter² (kg/m²)
  • current pregnancy
  • Volunteer in period of exclusion from further research
  • Person under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty

Outcomes

Primary Outcomes

time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation

Time Frame: through study completion, an average of 1 year

Difference between the time when volunteer enters the operating room and the time when the conditions for general anaesthesia are met during pre-oxygenation with the face mask applied by one anaesthesist in charge of the volunteer (simulated patient) compared to the use of preoxygenation with THRIVE by one anaesthesist in charge of the volunteer

Secondary Outcomes

  • number of medication errors during the preparation(through study completion, an average of 1 year)
  • number of deviations from appropriate anaesthetic practices observed during preparation(through study completion, an average of 1 year)
  • time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation(through study completion, an average of 1 year)

Study Sites (1)

Loading locations...

Similar Trials