NCT04814628

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-06-25
• Completion: 2024-06-25
• First posted: 2021-03-24
• Last updated: 2024-07-25

Locations

1 site across 1 country: France