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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Cesarean Section Complications; Anesthesia
• Intervention / Treatment: Procedure: scenario 1 : pre-oxygenation with a face mask held by the anaesthetist; Procedure: scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation; Procedure: scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation; Procedure: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: healthy volunteer subject; A single healthy volunteer subject will participate in the study as a model of a pregnant woman in the third trimester of pregnancy, with a functional respiratory capacity reduced by 20% thanks to elastic restraints performed under the control of functional respiratory explorations. 8 obstetric anesthesiologists will participate in the 4 scenarios;

Procedure: scenario 1 : pre-oxygenation with a face mask held by the anaesthetist; the face mask is held by the anaesthetist (reference technique) to obtain effective pre-oxygenation for Oxygen Reserve Index (ORI) which has reached a plateau value for more than 10 seconds. All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: Patient lying on the operating table, start of the stopwatch; Opening of the computerized anaesthesia file; Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient; Preparation of the hypnotic (propofol or thiopental, as desired); Preparation of curare (succinylcholine or rocuronium, as desired); Pre-oxygenation of the patient with the face mask held by the participating anaesthetist; Waiting for an ORI which has reached a plateau value for more than 10 seconds; Conditions for general anaesthesia met for the participating anaesthetist; "End of simulation", stopwatch stop; Procedure: scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation; one anaesthetist is in charge of the simulated patient (volunteer), face mask held by the volunteer for pre-oxygenation for ORI which has reached a plateau value for more than 10 seconds All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: Patient entering the operating room, patient lying on the operating table, start of the stopwatch; Opening of the computerized anaesthesia file; Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient; Preparation of the hypnotic (propofol or thiopental, as desired); Preparation of curare (succinylcholine or rocuronium, as desired); Face mask held by the patient for pre-oxygenation; Waiting for an ORI which has reached a plateau value for more than 10 seconds; Conditions for general anaesthesia met for the participating anaesthetist; "End of simulation", stopwatch stop; Procedure: scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation; All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: Patient entering the operating room, patient lying on the operating table, start of the stopwatch; Opening of the computerized anaesthesia file; Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient; Preparation of the hypnotic (propofol or thiopental, as desired); Preparation of curare (succinylcholine or rocuronium, as desired); THRIVE for pre-oxygenation; Waiting for an ORI which has reached a plateau value for more than 10 seconds; Conditions for general anaesthesia met for the participating anaesthetist; "End of simulation", stopwatch stop; Procedure: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist; All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: Patient entering the operating room, patient lying on the operating table, start of the stopwatch; Opening of the computerized anaesthesia file; Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient; Preparation of the hypnotic (propofol or thiopental, as desired); Preparation of curare (succinylcholine or rocuronium, as desired); Pre-oxygenation of the patient with the face mask held by the participating anaesthetist or nurse anaesthetist; Waiting for an ORI which has reached a plateau value for more than 10 seconds; Conditions for general anaesthesia met for the participating anaesthetist; "End of simulation", stopwatch stop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation	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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation	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	through study completion, an average of 1 year
number of medication errors during the preparation	Medication errors occurring during treatment in the 4 scenarios will be counted (medication preparation errors, no medication is administered to the volunteer)	through study completion, an average of 1 year
number of deviations from appropriate anaesthetic practices observed during preparation	The number of deviations from the appropriate anesthetic practices observed during the preparation will be counted in the 4 scenarios	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: maternal preoxygenation; ventilatory exchange
• Other Study ID Numbers: 69HCL20_1116; 2021-A00047-34 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No