High-flow nasal oxygen plus non-invasive ventilation to prevent low oxygen during intubation in obese adults

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

This test compares adding high-flow nasal oxygen to non-invasive ventilation to help obese adults keep their oxygen levels during induction of general anesthesia and intubation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Clinique Pasteur (other)
• Locations: 5 sites (Clermont-Ferrand and 4 other locations)
• Trial ID: NCT06914401 on ClinicalTrials.gov

What this trial studies

Obese patients have reduced lung reserve and higher risk of desaturation and airway difficulty during induction and intubation. This study compares two preoxygenation strategies in the operating room: non-invasive ventilation (NIV) alone versus NIV combined with high-flow nasal oxygen (HFNO). Eligible obese adults undergoing orotracheal intubation will receive one of the two oxygenation approaches and clinicians will monitor oxygen saturation, episodes of desaturation, and airway/ventilation complications during induction. The aim is to see whether the combined NIV+HFNO approach prolongs safe apnea time and lowers peri-intubation hypoxemia compared with NIV alone.

Who should consider this trial

Good fit: Adults with BMI ≥ 30 kg/m2 scheduled for general anesthesia with orotracheal intubation who can give informed consent and are covered by a social security scheme are the intended participants.

Not a fit: Patients with contraindications to NIV or HFNO, those needing fiberoptic or nasotracheal intubation, emergency cases without time for consent, pregnant or legally protected individuals, or those with hemodynamic instability are unlikely to be eligible or to benefit from the interventions tested.

Why it matters

Potential benefit: If successful, combining HFNO with NIV could reduce dangerous drops in oxygen and decrease complications during induction and intubation for obese patients.

How similar studies have performed: Previous studies show HFNO and NIV separately can improve oxygenation and safe apnea time, and early evidence supports that combining them may further reduce desaturation though results remain preliminary.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Haemodynamic instability
* Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
* Emergency surgery not allowing patient consent.
* 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.

Where this trial is running

Clermont-Ferrand and 4 other locations

• CHU Clermont Ferrand - Site Estaing — Clermont-Ferrand, France (RECRUITING)
• Clinique Honoré Cave — Montauban, France (RECRUITING)
• Hôpital Saint Eloi - CHU Montpellier — Montpellier, France (RECRUITING)
• Clinique Mutualiste La Sagesse — Rennes, France (RECRUITING)
• Clinique Pasteur — Toulouse, France (RECRUITING)

Study contacts

• Principal investigator: Ségolène MROZEK, MD, PhD — Clinique Pasteur
• Study coordinator: Ségolène MROZEK, MD, PhD

Conditions: Anesthesia Induction, Non Invasive Ventilation, High Flow Nasal Oxygen, Intubation, Obese