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

NCT04814628 | Completed

• 2 other identifiers: 69HCL20_11162021-A00047-34
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications; Pregnancy Related; Anesthesia

Keywords

maternal preoxygenation; ventilatory exchange

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• number of medication errors during the preparation

  through study completion, an average of 1 year

• number of deviations from appropriate anaesthetic practices observed during preparation

  through study completion, an average of 1 year

Study Arms (1)

healthy volunteer subject

EXPERIMENTAL

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; 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

Interventions

scenario 1 : pre-oxygenation with a face mask held by the anaesthetist PROCEDURE

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: 1. Patient lying on the operating table, start of the stopwatch 2. Opening of the computerized anaesthesia file 3. Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient 4. Preparation of the hypnotic (propofol or thiopental, as desired) 5. Preparation of curare (succinylcholine or rocuronium, as desired) 6. Pre-oxygenation of the patient with the face mask held by the participating anaesthetist 7. Waiting for an ORI which has reached a plateau value for more than 10 seconds 8. Conditions for general anaesthesia met for the participating anaesthetist 9. "End of simulation", stopwatch stop

healthy volunteer subject

scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation PROCEDURE

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: 1. Patient entering the operating room, patient lying on the operating table, start of the stopwatch 2. Opening of the computerized anaesthesia file 3. Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient 4. Preparation of the hypnotic (propofol or thiopental, as desired) 5. Preparation of curare (succinylcholine or rocuronium, as desired) 6. Face mask held by the patient for pre-oxygenation 7. Waiting for an ORI which has reached a plateau value for more than 10 seconds 8. Conditions for general anaesthesia met for the participating anaesthetist 9. "End of simulation", stopwatch stop

healthy volunteer subject

scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation PROCEDURE

All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: 1. Patient entering the operating room, patient lying on the operating table, start of the stopwatch 2. Opening of the computerized anaesthesia file 3. Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient 4. Preparation of the hypnotic (propofol or thiopental, as desired) 5. Preparation of curare (succinylcholine or rocuronium, as desired) 6. THRIVE for pre-oxygenation 7. Waiting for an ORI which has reached a plateau value for more than 10 seconds 8. Conditions for general anaesthesia met for the participating anaesthetist 9. "End of simulation", stopwatch stop

healthy volunteer subject

scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist PROCEDURE

All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows: 1. Patient entering the operating room, patient lying on the operating table, start of the stopwatch 2. Opening of the computerized anaesthesia file 3. Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient 4. Preparation of the hypnotic (propofol or thiopental, as desired) 5. Preparation of curare (succinylcholine or rocuronium, as desired) 6. Pre-oxygenation of the patient with the face mask held by the participating anaesthetist or nurse anaesthetist 7. Waiting for an ORI which has reached a plateau value for more than 10 seconds 8. Conditions for general anaesthesia met for the participating anaesthetist 9. "End of simulation", stopwatch stop

healthy volunteer subject

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Person under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Femme Mère Enfant

Bron, 69500, France

Location

MeSH Terms

Interventions

Fees and Charges

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: February 15, 2024
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

FR (1)