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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
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;
Intervention: scenario 1 : pre-oxygenation with a face mask held by the anaesthetist (Procedure)
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;
Intervention: scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation (Procedure)
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;
Intervention: scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation (Procedure)
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;
Intervention: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist (Procedure)
Outcomes
Primary Outcomes
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation
Time Frame: through study completion, an average of 1 year
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
Secondary Outcomes
- 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)
- 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)