Assessment of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) for Maternal Pre-oxygenation

Not Applicable

Completed

• Conditions: Pregnancy Related; Cesarean Section Complications; Anesthesia

• Registration Number: NCT04814628
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2024-02-15
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• major
• female
• 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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation	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 Outcome Measures

Name	Time	Method
number of medication errors during the preparation	through study completion, an average of 1 year	Medication errors occurring during treatment in the 4 scenarios will be counted (medication preparation errors, no medication is administered to the volunteer)
number of deviations from appropriate anaesthetic practices observed during preparation	through study completion, an average of 1 year	The number of deviations from the appropriate anesthetic practices observed during the preparation will be counted in the 4 scenarios
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	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 anaesthetist in charge of the volunteer (simulated patient), during pre-oxygenation with the face mask applied by the volunteer (one anaesthetist in charge of the simulated patient), during preoxygenation with THRIVE (one anaesthetist in charge of the simulated patient), during preoxygenation with the facemask applied by the anaesthetist or the nurse anaesthetist both in charge of the simulated patient

Trial Locations

Locations (1)

Hopital Femme Mère Enfant; 🇫🇷 Bron, France