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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
First received
Last updated
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
Health authority
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/meterĀ² (kg/mĀ²) - 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 Design


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
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