Preoxygenation Optimisation in Obese Patients (PREOPTI-POOP)

PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "

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

Study Overview

• Status: Completed
• Conditions: Severe Obesity Design as BMI > 35kg/m2
• Intervention / Treatment: Device: High flow oxygen therapy by nasal cannula. Optiflow®; Device: Facial mask oxygenation in BIPAP ventilation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High flow oxygen therapy by nasal cannula; Experimental Device : High flow oxygen therapy by nasal cannula.	Device: High flow oxygen therapy by nasal cannula. Optiflow®; Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
ACTIVE_COMPARATOR: Facial mask oxygenation in BIPAP ventilation; Active Comparator: Facial mask oxygenation in BIPAP ventilation	Device: Facial mask oxygenation in BIPAP ventilation; Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expired fraction of oxygen at the end of intubation	To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of quality of preoxygenation	duration of proceedings	4 minutes
Reduction in side effects incidence related to intubation	Notification of adverse events during the intubation period	1 hour
morbi-mortality during surgery	Per and postoperative complication rate	6 hour

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Karim Asehnoune, PHD, Nantes University Hospital

Publications and helpful links

General Publications

• Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ACTUAL): April 12, 2018
• Study Completion (ACTUAL): April 12, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: RC17_0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No