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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Anesthesia, Cesarean Section Complications, Pregnancy Related

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteer subject<br>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<br>* 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<br>Procedure: scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation<br>* 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<br>Procedure: scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation<br>* 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<br>Procedure: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal preoxygenation, ventilatory exchange