NCT05930678

Brief 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 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
725

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

June 1, 2023

Last Update Submit

March 10, 2026

Conditions

Morbid ObesityVentilation Therapy; Complications

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    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

    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

    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

    During the general anesthesia, up to 8 hours

  • +18 more secondary outcomes

Study Arms (2)

Without ventilation

ACTIVE COMPARATOR

No ventilation sequence during the intubation period and without face mask ventilation during the apnea period

Procedure: No ventilation with face mask

With ventilation

EXPERIMENTAL

Sequence "with ventilation" during the apnea period with face mask ventilation

Procedure: Ventilation with face mask

Interventions

No ventilation with face maskPROCEDURE

During the period of apnea (in general anesthesia), the patient did not help with face mask

Without ventilation
Ventilation with face maskPROCEDURE

During the pperiod of apnea (in general anesthesia), the patient did help with face mask

With ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Nantes

Nantes, Loire Atlantique, 44100, France

Location

CHU Angers

Angers, 49933, France

Location

CHRU Brest

Brest, 29609, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CHRU de Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

HCL - Hôpital Edouard Herriot

Lyon, France

Location

CHU de Nantes - site Laennec

Nantes, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CH de Saint-Nazaire

Saint-Nazaire, 44600, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

CHU Toulouse

Toulouse, 31300, France

Location

CH de Valenciennes

Valenciennes, France

Location

Related Publications (1)

  • 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.

    PMID: 41219812DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

MasksVentilation

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and AgricultureEnvironment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Mickael VOURC'H, PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Morbidly obese patients (BMI greater than or equal to 35).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

July 5, 2023

Study Start

September 12, 2023

Primary Completion

June 24, 2025

Study Completion

July 3, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

FR(13)