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NCT06914401Completed

Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

Oxygenation Procedure for Obese Patients Using High Flow Oxygen Therapy Combined With Non-invasive Ventilation During Intubation in the Operating Room: a Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.

Status (registry)
Completed
Study type
Interventional
Enrollment
124 (actual)
First submitted
28 Mar 2025
Start date
19 Jun 2025
Primary completion date
4 May 2026
Lead sponsor
Clinique Pasteur
Diseases
Obesity
NCT number
NCT06914401

What you commit to

  • Study type: Interventional
  • Participants enrolled: 124
  • From 19 Jun 2025 to the primary completion date, 4 May 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergency surgery not allowing patient consent.

Other

  • Haemodynamic instability
  • Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
  • Patient with a contraindication to NIV or OHD
  • Protected patients: Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; pregnant, breast-feeding or parturient women; hospitalised without consent.

Who the study is looking for

  • Patient requiring general anaesthesia with orotracheal intubation in the operating room
  • Obese patient (Body Mass Index , BMI ≥ 30kg/m2)
  • Patient affiliated to or benefiting from a social security scheme
  • Patient having signed the free and informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Clermont-Ferrand Site Estaing
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Clinique Honoré Cave
Coordinator of this site? Confirm its status
MontaubanFranceUnknown status
Hôpital saint Eloi CHU Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Clinique Mutualiste La Sagesse
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Clinique Pasteur
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.