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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04814628

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications Pregnancy Related Anesthesia	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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.

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Femme Mère Enfant	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04814628

Other Study ID Numbers:

69HCL20_1116
2021-A00047-34

First Posted:

Mar 24, 2021

Last Update Posted:

Oct 25, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

maternal preoxygenation

ventilatory exchange

Study Results

No Results Posted as of Oct 25, 2021