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

Anesthesia Clinical Trial

— PREOXCE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04814628
• Other study ID #: 69HCL20_1116
• Secondary ID: 2021-A00047-34
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Lionel BOUVET, MD,PhD
• Phone: 0 4 72 12 97 63
• Email: lionel.bouvet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cesarean Section Complications
• Pregnancy Related

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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