Skip to main content
OpenTrials
Completed

NCT Number: NCT04814628

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Complications Anesthesia Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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:

  • Patient lying on the operating table, start of the stopwatch
  • Opening of the computerized anaesthesia file
  • Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
  • Preparation of the hypnotic (propofol or thiopental, as desired)
  • Preparation of curare (succinylcholine or rocuronium, as desired)
  • Pre-oxygenation of the patient with the face mask held by the participating anaesthetist
  • Waiting for an ORI which has reached a plateau value for more than 10 seconds
  • Conditions for general anaesthesia met for the participating anaesthetist
  • "End of simulation", stopwatch stop

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

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:

  • Patient entering the operating room, patient lying on the operating table, start of the stopwatch
  • Opening of the computerized anaesthesia file
  • Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
  • Preparation of the hypnotic (propofol or thiopental, as desired)
  • Preparation of curare (succinylcholine or rocuronium, as desired)
  • Face mask held by the patient for pre-oxygenation
  • Waiting for an ORI which has reached a plateau value for more than 10 seconds
  • Conditions for general anaesthesia met for the participating anaesthetist
  • "End of simulation", stopwatch stop

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

Procedure

All the usual supplies and medicines are available and in the same place as usual.

The sequence is as follows:

  • Patient entering the operating room, patient lying on the operating table, start of the stopwatch
  • Opening of the computerized anaesthesia file
  • Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
  • Preparation of the hypnotic (propofol or thiopental, as desired)
  • Preparation of curare (succinylcholine or rocuronium, as desired)
  • THRIVE for pre-oxygenation
  • Waiting for an ORI which has reached a plateau value for more than 10 seconds
  • Conditions for general anaesthesia met for the participating anaesthetist
  • "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

Procedure

All the usual supplies and medicines are available and in the same place as usual.

The sequence is as follows:

  • Patient entering the operating room, patient lying on the operating table, start of the stopwatch
  • Opening of the computerized anaesthesia file
  • Monitoring (ECG, non-invasive blood pressure, SaO2) of the patient
  • Preparation of the hypnotic (propofol or thiopental, as desired)
  • Preparation of curare (succinylcholine or rocuronium, as desired)
  • Pre-oxygenation of the patient with the face mask held by the participating anaesthetist or nurse anaesthetist
  • Waiting for an ORI which has reached a plateau value for more than 10 seconds
  • Conditions for general anaesthesia met for the participating anaesthetist
  • "End of simulation", stopwatch stop

Primary outcomes

  1. 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

  1. time between volunteer enters the operating room and when the conditions for general anaesthesia 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 anaesthetist in charge of the volunteer (simulated patient), during pre-oxygenation with the face mask applied by the volunteer (one anaesthetist in charge of the simulated patient), during preoxygenation with THRIVE (one anaesthetist in charge of the simulated patient), during preoxygenation with the facemask applied by the anaesthetist or the nurse anaesthetist both in charge of the simulated patient

  2. number of medication errors during the preparation

    Time frame: through study completion, an average of 1 year

    Medication errors occurring during treatment in the 4 scenarios will be counted (medication preparation errors, no medication is administered to the volunteer)

  3. number of deviations from appropriate anaesthetic practices observed during preparation

    Time frame: through study completion, an average of 1 year

    The number of deviations from the appropriate anesthetic practices observed during the preparation will be counted in the 4 scenarios

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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.

Acronym: PREOXCE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2021
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.