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

NCT04814628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-07-25

No results posted yet for this study

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

Interventions

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: 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

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: 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

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: 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

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: 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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-06-25
Completion
2024-06-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814628 on ClinicalTrials.gov