Preoxygenation Optimisation in Obese Patients (PREOPTI-POOP)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Severe Obesity Design as BMI > 35kg/m2

Treatments

Device: Facial mask oxygenation in BIPAP ventilation
Device: High flow oxygen therapy by nasal cannula. Optiflow®

Study type

Interventional

Funder types

Other

Identifiers

NCT03106441
RC17_0046

Details and patient eligibility

About

Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

Full description

This study will be designed as followed : Patients will be randomized in 2 groups : Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation. Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.

Enrollment

100 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Obese patient with BMI > 35kg/m2
  • Age between 18 and 80 years
  • Requiring a crash induction sequence for oro-tracheal intubation.

Exclusion criteria

  • Pulse oxymetry < 90% in ambient air
  • Haemodynamic instability
  • Burned patient
  • Indication of intubation vigil in spontaneous ventilation
  • Patients with a documented Cormack IV exposition before inclusion
  • Protected adult
  • Pregnancy
  • Lack of consent
  • Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.
  • Lack of French social protection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

High flow oxygen therapy by nasal cannula
Experimental group
Description:
Experimental Device : High flow oxygen therapy by nasal cannula.
Treatment:
Device: High flow oxygen therapy by nasal cannula. Optiflow®
Facial mask oxygenation in BIPAP ventilation
Active Comparator group
Description:
Active Comparator: Facial mask oxygenation in BIPAP ventilation
Treatment:
Device: Facial mask oxygenation in BIPAP ventilation

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems