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Preoxygenation Optimisation in Obese Patients (PREOPTI-POOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106441
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Severe Obesity Design as BMI > 35kg/m2 Device: High flow oxygen therapy by nasal cannula. Optiflow® Device: Facial mask oxygenation in BIPAP ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "
Actual Study Start Date : June 21, 2017
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : April 12, 2018

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Improvement of quality of preoxygenation [ Time Frame: 4 minutes ]
    duration of proceedings

  2. Reduction in side effects incidence related to intubation [ Time Frame: 1 hour ]
    Notification of adverse events during the intubation period

  3. morbi-mortality during surgery [ Time Frame: 6 hour ]
    Per and postoperative complication rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106441


Locations
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France
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Karim Asehnoune, PHD Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03106441    
Other Study ID Numbers: RC17_0046
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight