search
Back to results

Preoxygenation Optimisation in Obese Patients (PREOPTI-POOP)

Primary Purpose

Severe Obesity Design as BMI > 35kg/m2

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High flow oxygen therapy by nasal cannula. Optiflow®
Facial mask oxygenation in BIPAP ventilation
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity Design as BMI > 35kg/m2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow oxygen therapy by nasal cannula

Facial mask oxygenation in BIPAP ventilation

Arm Description

Experimental Device : High flow oxygen therapy by nasal cannula.

Active Comparator: Facial mask oxygenation in BIPAP ventilation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvement of quality of preoxygenation
duration of proceedings
Reduction in side effects incidence related to intubation
Notification of adverse events during the intubation period
morbi-mortality during surgery
Per and postoperative complication rate

Full Information

First Posted
March 28, 2017
Last Updated
September 3, 2018
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03106441
Brief Title
Preoxygenation Optimisation in Obese Patients
Acronym
PREOPTI-POOP
Official Title
PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity Design as BMI > 35kg/m2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow oxygen therapy by nasal cannula
Arm Type
Experimental
Arm Description
Experimental Device : High flow oxygen therapy by nasal cannula.
Arm Title
Facial mask oxygenation in BIPAP ventilation
Arm Type
Active Comparator
Arm Description
Active Comparator: Facial mask oxygenation in BIPAP ventilation
Intervention Type
Device
Intervention Name(s)
High flow oxygen therapy by nasal cannula. Optiflow®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Facial mask oxygenation in BIPAP ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
Expired fraction of oxygen at the end of intubation
Description
To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Improvement of quality of preoxygenation
Description
duration of proceedings
Time Frame
4 minutes
Title
Reduction in side effects incidence related to intubation
Description
Notification of adverse events during the intubation period
Time Frame
1 hour
Title
morbi-mortality during surgery
Description
Per and postoperative complication rate
Time Frame
6 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Asehnoune, PHD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31528849
Citation
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.
Results Reference
derived

Learn more about this trial

Preoxygenation Optimisation in Obese Patients

We'll reach out to this number within 24 hrs