Cesarean Section ComplicationsPREOXCENCT04814628
Assessment of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) for Maternal Pre-oxygenation
A study testing scenario 1 : pre-oxygenation with a face mask held by the anaesthetist, scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation and scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation in people with Cesarean Section Complications and Pregnancy Related, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Pregnancy Related, Anesthesia
- What is being tested?
- scenario 1 : pre-oxygenation with a face mask held by the anaesthetist, scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation and scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2024to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Being tested
- scenario 1 : pre-oxygenation with a face mask held by the anaesthetist, scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation, scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation, scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist
- Keywords
- maternal preoxygenation, ventilatory exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scenario 1 : pre-oxygenation with a face mask held by the anaesthetistProcedure or surgery
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-oxygenationProcedure or surgery
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-oxygenationProcedure or surgery
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 anaesthetistProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteer subject | Experimental | 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; Receives: Procedure: scenario 1 : pre-oxygenation with a face mask held by the 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; Procedure: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist |
What is being measured
The primary outcome is the main question the study is designed to answer.
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation
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
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation
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
Measured: through study completion, an average of 1 year
number of medication errors during the preparation
Medication errors occurring during treatment in the 4 scenarios will be counted (medication preparation errors, no medication is administered to the volunteer)
Measured: through study completion, an average of 1 year
number of deviations from appropriate anaesthetic practices observed during preparation
The number of deviations from the appropriate anesthetic practices observed during the preparation will be counted in the 4 scenarios
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start15 Feb 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814628
- Sponsor's protocol ID
- 69HCL20_1116
- Other IDs
- 2021-A00047-34
- Acronym
- PREOXCE
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04814628
- Acronym / sponsor ID
- PREOXCE / 69HCL20_1116
- Keywords
- maternal preoxygenation, ventilatory exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteer subject | Experimental | Procedure: scenario 1 : pre-oxygenation with a face mask held by the 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, Procedure: scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetistA 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; |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scenario 1 : pre-oxygenation with a face mask held by the anaesthetistthe 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 or surgery | healthy volunteer subject |
| scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenationone 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 or surgery | healthy volunteer subject |
| scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenationAll 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 or surgery | healthy volunteer subject |
| scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetistAll 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 | Procedure or surgery | healthy volunteer subject |
Primary outcome
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
3 secondary outcomes
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
number of medication errors during the preparation
Time frame: through study completion, an average of 1 year
number of deviations from appropriate anaesthetic practices observed during preparation
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scenario 1 : pre-oxygenation with a face mask held by the anaesthetist, scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation and scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation in people with Cesarean Section Complications and Pregnancy Related, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.