Morbid ObesityVENT OR NOTNCT05930678
Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation
A study testing No ventilation with face mask and Ventilation with face mask in people with Morbid Obesity and Ventilation Therapy; Complications, run by Nantes University Hospital at 13 sites in France.
Trial summary
The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Ventilation Therapy; Complications
- What is being tested?
- No ventilation with face mask and Ventilation with face mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 13 sitesFrance
- Study dates
- 12 Sep 2023to 3 Jul 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
- age > 18 years
- with a BMI superior or equal to 35kg.m-²
- patient having signed an informed consent
- Non-inclusion criteria:
- ambient air saturation <90%
Show all 16Show fewer
- urgent surgery < 24 hours
- cardio-thoracic surgery
- mask ventilation not possible (e.g. ATCD, cervical irradiation, fixed mandible)
- formal contraindication to mask ventilation (e.g. occlusive syndrome, non fasting patient, symptomatic gastroesophageal reflux untreated or persistent under treatment)
- wish of the operator for high flow oxygen preoxygenation
- wish of an intubation without curare by the operator
- pregnant or breast-feeding women
- protected adults (guardianship, curatorship or safeguard of justice)
- participation in another randomized clinical research study concerning preoxygenation and relevant to the primary endpoint
- absence of affiliation to the French social security system
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers
Angers, 49933
CHRU Brest
Brest, 29609
CHU de Dijon
Dijon, 21000
CHD Vendée
La Roche-sur-Yon, 85925
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037
HCL - Hôpital Edouard Herriot
Lyon
CHU Nantes
Nantes, Loire Atlantique, 44100
CHU de Nantes - site Laennec
Nantes
CHU de Rennes
Rennes, 35033
CH de Saint-Nazaire
Saint-Nazaire, 44600
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600
CHU Toulouse
Toulouse, 31300
CH de Valenciennes
Valenciennes
About this study
Official title: Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation. A Randomized Multicentre Study
The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.
Read the detailed description
Anesthesia consultation or pre-anesthesia visit:
- screening for inclusion and non-inclusion criteria
- patient information
- collection of consent
- inclusion
D0 (day of inclusion):
- before general anesthesia : collection of epidemiological data (history + clinical examinations) + randomization (Arm A/Not Vent : intubation without ventilation or Arm B/Vent : intubation with ventilation)
- general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure
- after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity
- post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)
- Conditions
- Morbid Obesity, Ventilation Therapy; Complications
- Being tested
- No ventilation with face mask, Ventilation with face mask
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No ventilation with face maskProcedure or surgery
During the period of apnea (in general anesthesia), the patient did not help with face mask
Ventilation with face maskProcedure or surgery
During the pperiod of apnea (in general anesthesia), the patient did help with face mask
| Study group | Role | What they receive |
|---|---|---|
| Without ventilation | Active comparator | No ventilation sequence during the intubation period and without face mask ventilation during the apnea period Receives: Procedure: No ventilation with face mask |
| With ventilation | Experimental | Sequence "with ventilation" during the apnea period with face mask ventilation Receives: Procedure: Ventilation with face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room
Comparison of the incidence of intubation-related complications. Complications identified for the primary endpoint will be: desaturations < 95%, need for 2 or more intubation attempts (including alternative technique), occurrence of inhalation/regurgitation or hypotension with systolic blood pressure < 80 mmHg, with or without amine. Complications will be recorded from induction of general anesthesia to 10 minutes after intubation
Measured: From induction of general anesthesia to 10 minutes after intubation
Secondary outcomes (23)
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Difficulty with mask ventilation (yes/no)
Measured: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Measure of the saturation before the first laryngoscopy with oximeter
Measured: During the general anesthesia, up to 10 minutes
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Measure of the lowest saturation during the intubation procedure and the following 10 minutes
Measured: During the general anesthesia, up to 10 minutes
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Quality of exposure under laryngoscopy (position of the patient)
Measured: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Difficulties in intubation (yes/no)
Measured: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Description of intubation (mandrin, videolaryngoscope, videolaryngoscope)
Measured: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Rate of desaturation <80% (yes/no)
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Rate of desaturation <90% (yes/no)
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Presence of severe hypotension during intubation and in the following hour defined by a systolic blood pressure < 80 mmHg, with or without amine (yes/no)
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Number of participants with cardiac arrest
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Death during intubation
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Difficulties in intubations (yes/no) with the number of intubation attempts
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Number of participants with cardiac rhythm disorders
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Number of participants with esophageal intubations
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Number of participants with regurgitation/inhalation
Measured: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Number of participants with dental breaks
Measured: up to 8 hours
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Need for FiO2 >50% during surgery to achieve >95% saturation (yes/no)
Measured: 5 minutes, 30 minutes and 1 hour after intubation
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Length of stay in the post-operation monitoring room
Measured: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Duration of postoperative mechanical ventilation(in minutes)
Measured: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Number of participants with nausea
Measured: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Number of participants with vomiting
Measured: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Length of hospitalization since randomization
Measured: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Hospital discharge status (dead/alive)
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Sep 2023
- Primary completion24 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Morbidly obese patients (BMI greater than or equal to 35).
- Masking
- None (open label)
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael VOURC'H, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930678
- Sponsor's protocol ID
- RC22_0359
- Acronym
- VENT OR NOT
- Status last verified
- Mar 2026
- First submitted
- 1 Jun 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Znaidi S, Deransy R, Asehnoune K, Le Penndu M, Rozec B, Jumel G, Lasocki S, Cadic-Pelletier A, Guinot PG, Duchalais A, Cirenei C, Abrard S, Beloeil H, Fortuit C, Landrin J, Porta Bonete G, Defrancq F, Pere M, Vourc'h M. Intubation of obese patients in the operating room with or without bag-mask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT). Trials. 2025 Nov 11;26(1):492. doi: 10.1186/s13063-025-09114-z.
PubMed 41219812
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation. A Randomized Multicentre Study
- ClinicalTrials.gov ID
- NCT05930678
- Acronym / sponsor ID
- VENT OR NOT / RC22_0359
- Conditions
- Morbid Obesity, Ventilation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 5 Jul 2023 (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 aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.
Detailed description
Anesthesia consultation or pre-anesthesia visit:
- screening for inclusion and non-inclusion criteria
- patient information
- collection of consent
- inclusion
D0 (day of inclusion):
- before general anesthesia : collection of epidemiological data (history + clinical examinations) + randomization (Arm A/Not Vent : intubation without ventilation or Arm B/Vent : intubation with ventilation)
- general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure
- after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity
- post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Morbidly obese patients (BMI greater than or equal to 35).
| Arm | Type | Receives |
|---|---|---|
| Without ventilation | Active comparator | Procedure: No ventilation with face maskNo ventilation sequence during the intubation period and without face mask ventilation during the apnea period |
| With ventilation | Experimental | Procedure: Ventilation with face maskSequence "with ventilation" during the apnea period with face mask ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
- age > 18 years
- with a BMI superior or equal to 35kg.m-²
- patient having signed an informed consent
- ambient air saturation <90%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No ventilation with face maskDuring the period of apnea (in general anesthesia), the patient did not help with face mask | Procedure or surgery | Without ventilation |
| Ventilation with face maskDuring the pperiod of apnea (in general anesthesia), the patient did help with face mask | Procedure or surgery | With ventilation |
Primary outcome
To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room
Time frame: From induction of general anesthesia to 10 minutes after intubation
Comparison of the incidence of intubation-related complications. Complications identified for the primary endpoint will be: desaturations < 95%, need for 2 or more intubation attempts (including alternative technique), occurrence of inhalation/regurgitation or hypotension with systolic blood pressure < 80 mmHg, with or without amine. Complications will be recorded from induction of general anesthesia to 10 minutes after intubation
23 secondary outcomes
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 10 minutes
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 10 minutes
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
Time frame: During the general anesthesia, up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
Time frame: up to 8 hours
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: 5 minutes, 30 minutes and 1 hour after intubation
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
Time frame: up to 28 days
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 12 Mar 2026.
- Derived from this study: PubMed 41219812Znaidi S, Deransy R, Asehnoune K, Le Penndu M, Rozec B, Jumel G, Lasocki S, Cadic-Pelletier A, Guinot PG, Duchalais A, Cirenei C, Abrard S, Beloeil H, Fortuit C, Landrin J, Porta Bonete G, Defrancq F, Pere M, Vourc'h M. Intubation of obese patients in the operating room with or without bag-mask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT). Trials. 2025 Nov 11;26(1):492. doi: 10.1186/s13063-025-09114-z.
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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.
Mickael VOURC'H, PhD principal investigator
Nantes University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No ventilation with face mask and Ventilation with face mask in people with Morbid Obesity and Ventilation Therapy; Complications, run by Nantes University Hospital at 13 sites 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 16 inclusion and 0 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room (time frame: From induction of general anesthesia to 10 minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930678, which also lists 1 linked publication.
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 12 Mar 2026.