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Oxygenation Procedure for Obese Patients During Intubation in the Operating Room (POP-OVNI)

C

Clinique Pasteur

Status

Not yet enrolling

Conditions

Anesthesia Induction

Treatments

Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen)
Procedure: NIV (Non Invasive Ventilation)

Study type

Interventional

Funder types

Other

Identifiers

NCT06914401
2024-A02304-43

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 2 patient groups

Combined oxygenation procedure
Active Comparator group
Treatment:
Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen)
Single oxygenation procedure
Active Comparator group
Treatment:
Procedure: NIV (Non Invasive Ventilation)

Trial contacts and locations

1

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Central trial contact

Stéphanie SAVY, PhD; Ségolène MROZEK, MD, PhD

Data sourced from clinicaltrials.gov

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