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

Civil Hospices of Lyon

Status: Completed

Conditions: Cesarean Section Complications; Pregnancy Related; Anesthesia

Treatments: Procedure: scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation; Procedure: scenario 2: one anaesthetist in charge, face mask held by the patient 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; Procedure: scenario 1 : pre-oxygenation with a face mask held by the anaesthetist

Study type: Interventional

Funder types: Other

Identifiers

NCT04814628

69HCL20_1116

2021-A00047-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

healthy volunteer subject

Experimental group

Description:

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;

Treatment:

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

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