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Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation (VENT OR NOT)

Primary Purpose

Morbid Obesity, Ventilation Therapy; Complications

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
No ventilation with face mask
Ventilation with face mask
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Morbid Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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% 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

Sites / Locations

  • CHU NantesRecruiting
  • CHU AngersRecruiting
  • CHRU Brest
  • HCL - Hôpital Edouard HerriotRecruiting
  • CHU de Nantes - site LaennecRecruiting
  • CHU Poitiers
  • CHU Toulouse
  • CHRU Tours
  • CH de Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Without ventilation

With ventilation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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)
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
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)
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
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
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
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)

Full Information

First Posted
June 1, 2023
Last Updated
October 5, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05930678
Brief Title
Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation
Acronym
VENT OR NOT
Official Title
Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation. A Randomized Multicentre Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
September 12, 2025 (Anticipated)
Study Completion Date
September 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Ventilation Therapy; Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Morbidly obese patients (BMI greater than or equal to 35).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
702 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without ventilation
Arm Type
Active Comparator
Arm Description
No ventilation sequence during the intubation period and without face mask ventilation during the apnea period
Arm Title
With ventilation
Arm Type
Experimental
Arm Description
Sequence "with ventilation" during the apnea period with face mask ventilation
Intervention Type
Procedure
Intervention Name(s)
No ventilation with face mask
Intervention Description
During the period of apnea (in general anesthesia), the patient did not help with face mask
Intervention Type
Procedure
Intervention Name(s)
Ventilation with face mask
Intervention Description
During the pperiod of apnea (in general anesthesia), the patient did help with face mask
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
From induction of general anesthesia to 10 minutes after intubation
Secondary Outcome Measure Information:
Title
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
Difficulty with mask ventilation (yes/no)
Time Frame
During the general anesthesia, up to 8 hours
Title
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
Measure of the saturation before the first laryngoscopy with oximeter
Time Frame
During the general anesthesia, up to 10 minutes
Title
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
Measure of the lowest saturation during the intubation procedure and the following 10 minutes
Time Frame
During the general anesthesia, up to 10 minutes
Title
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
Quality of exposure under laryngoscopy (position of the patient)
Time Frame
During the general anesthesia, up to 8 hours
Title
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
Difficulties in intubation (yes/no)
Time Frame
During the general anesthesia, up to 8 hours
Title
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
Description of intubation (mandrin, videolaryngoscope, videolaryngoscope)
Time Frame
During the general anesthesia, up to 8 hours
Title
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
Description
Rate of desaturation <80% (yes/no)
Time Frame
up to 8 hours
Title
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
Description
Rate of desaturation <90% (yes/no)
Time Frame
up to 8 hours
Title
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
Description
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)
Time Frame
up to 8 hours
Title
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
Description
Number of participants with cardiac arrest
Time Frame
up to 8 hours
Title
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
Description
Death during intubation
Time Frame
up to 8 hours
Title
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
Description
Difficulties in intubations (yes/no) with the number of intubation attempts
Time Frame
up to 8 hours
Title
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
Description
Number of participants with cardiac rhythm disorders
Time Frame
up to 8 hours
Title
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
Description
Number of participants with esophageal intubations
Time Frame
up to 8 hours
Title
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
Description
Number of participants with regurgitation/inhalation
Time Frame
up to 8 hours
Title
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
Description
Number of participants with dental breaks
Time Frame
up to 8 hours
Title
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
Description
Need for FiO2 >50% during surgery to achieve >95% saturation (yes/no)
Time Frame
5 minutes, 30 minutes and 1 hour after intubation
Title
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
Description
Length of stay in the post-operation monitoring room
Time Frame
up to 28 days
Title
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
Description
Duration of postoperative mechanical ventilation(in minutes)
Time Frame
up to 28 days
Title
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
Description
Number of participants with nausea
Time Frame
up to 28 days
Title
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
Description
Number of participants with vomiting
Time Frame
up to 28 days
Title
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
Description
Length of hospitalization since randomization
Time Frame
up to 28 days
Title
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
Description
Hospital discharge status (dead/alive)
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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% 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mickael VOURC'H, PhD
Phone
0244768053
Email
mickael.vourch@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid GARREAU
Phone
0253482840
Email
astrid.garreau@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mickael VOURC'H, PhD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain DERANSY
Phone
0240082186
Email
romain.deransy@chu-nantes.fr
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigismond LASOCKI
Phone
0241353637
Email
sigismond@lasocki.com
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna CADIC-PELLETIER
Phone
0298223333
Email
anna.cadic@chu-brest.fr
Facility Name
HCL - Hôpital Edouard Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislas ABRARD
Phone
0472116944
Email
stanislas.abrard@chu-lyon.fr
Facility Name
CHU de Nantes - site Laennec
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael VOURC'H
Phone
0244768053
Email
mickael.vourch@chu-nantes.fr
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu BOISSON
Phone
0549444444
Email
matthieu.boisson@chu-poitiers.fr
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent MINVILLE
Phone
0561322791
Email
minville.v@chu-toulouse.fr
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis REMERAND
Phone
0247474747
Email
f.remerand@chu-tours.fr
Facility Name
CH de Valenciennes
City
Valenciennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanny DEFRANCQ
Phone
0327143333
Email
defrancq-f@ch-valenciennes.fr

12. IPD Sharing Statement

Learn more about this trial

Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation

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