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

NCT ID: NCT04814628

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-06-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

healthy volunteer subject

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;

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Intervention Type: 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

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

Intervention Type: 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

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Femme Mère Enfant

Bron, , France

Countries

France

Other Identifiers

2021-A00047-34

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_1116

Identifier Type: -

Identifier Source: org_study_id