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Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients (EXTUB-OBESE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04014920
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.

Condition or disease Intervention/treatment Phase
Obesity Ventilation Intensive Care Unit Device: Oxygen group Device: NIV Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients: a Prospective, Randomized, Multicenter Study
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Oxygen Group
Patient will receive standard oxygenotherapy
Device: Oxygen group
The control group will receive oxygen (first randomization), HFNO oxygen or standard oxygen (second randomization)

Experimental: NIV Group
Patient will receive non invasive ventilation
Device: NIV Group
The experimental group will receive NIV (first randomization) alternated with HFNO or standard oxygen (second randomization)




Primary Outcome Measures :
  1. The failure of the treatment, defined by a composite criteria [ Time Frame: 72 hours ]
    The failure of the treatment, defined by a composite criteria combining the treatment failure, defined as reintubation for mechanical ventilation, switch to the other study treatment, or premature study-treatment discontinuation


Secondary Outcome Measures :
  1. Incidence of acute respiratory failure [ Time Frame: up to Day 7 ]
    Occurrence of acute respiratory failure

  2. Oxygenation [ Time Frame: Up to Day 7 ]
    Oxygenation will be assessed based on the lowest SpO2 value and on PaO2/FiO2 (if available)

  3. Organ failure [ Time Frame: Up to Day 7 ]
    Number of organ failures as assessed by the daily SOFA score each day until Day-7

  4. ICU all-cause mortality [ Time Frame: up to day 28 ]
  5. Tracheal intubation rate [ Time Frame: up to day 28 ]
  6. Length of stay in ICU and in hospital [ Time Frame: up to day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (age ≥ 18 years)
  • Subjects must be covered by public health insurance
  • Obese patients defined by a body mass index ≥ 30 kg/m²
  • Extubation after a length of mechanical ventilation >= 6 hours
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

  • Refusal of study participation or to pursue the study by the patient
  • Hypercapnia with a formal indication for NIV (PaCO2 ≥ 50 mmHg, formal indication for NIV)
  • Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
  • Pregnancy or breastfeeding
  • Anatomical factors precluding the use of NIV and/or HFNO
  • Absence of coverage by the French statutory healthcare insurance system
  • Patients with tracheostomy
  • Patients with CPAP for obstructive apnea syndrome
  • Patients with decision of no-reintubate (limitation)

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): NCT04014920


Contacts
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Contact: Audrey DE JONG 0033467337271 a-de_jong@chu-montpellier.fr

Locations
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France
Centre Hospitalier Universitaire Saint Eloi Recruiting
Montpellier, Herault, France, 34000
Contact: Samir Jaber, MD, PHD    0033467337271    s-jaber@chu-montpellier.fr   
Contact: Audrey De Jong, MD, PHD    0033467337271    a-de_jong@chu-montpellier.fr   
Principal Investigator: Samir Jaber, MD, PHD         
Sub-Investigator: Audrey De Jong, MD, PHD         
Sub-Investigator: Gerald Chanques, MD, PHD         
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04014920    
Other Study ID Numbers: 7770
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 12 months after the main publication
Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No