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Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure

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ClinicalTrials.gov Identifier: NCT03832387
Recruitment Status : Completed
First Posted : February 6, 2019
Results First Posted : May 27, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Belenguer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary:

Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus oxygen therapy in patients with extubation failure was evaluated.

A clinical trial was conducted that included patients who underwent mechanical ventilation and developed acute respiratory failure after extubation. After extubation failure, thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.


Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Non-invasive mechanical ventilation Device: Continuous positive airway pressure Device: Venturi mask Device: Reservoir mask Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: STUDY GROUP: Non-invasive ventilation using BiPAP Vision and continuous positive airway pressure (CPAP) systems CONTROL GROUP: Oxygen therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Mechanical Ventilation Versus Oxygen Therapy in Patients With Acute Respiratory Failure After Extubation in a Intensive Care Unit
Actual Study Start Date : March 29, 2009
Actual Primary Completion Date : June 4, 2016
Actual Study Completion Date : September 4, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-invasive mechanical ventilation

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Device: Non-invasive mechanical ventilation
Device: Continuous positive airway pressure
Active Comparator: Venturi mask

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Device: Venturi mask
Device: Reservoir mask



Primary Outcome Measures :
  1. Rate of Intubation [ Time Frame: from randomization to 1 week ]
    Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy


Secondary Outcome Measures :
  1. Rate of Tracheotomy [ Time Frame: from randomization to 3 weeks ]
    Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation

  2. Intensive Care Unit Length of Stay [ Time Frame: From intensive care unit admission to 2 months ]
    Duration of stay at intensive care unit

  3. Hospital Length of Stay [ Time Frame: From hospital admission to 3 months ]
    Duration of stay at hospital

  4. Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy [ Time Frame: From randomization to one week ]
    Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.

  5. Duration of Global Mechanical Ventilation [ Time Frame: From start of mechanical ventilation to one month ]
    Duration of mechanical ventilation until unsupported ventilation

  6. Rate of Intensive Care Unit Mortality [ Time Frame: From intensive care unit admission to 2 months ]
    Mortality during intensive care unit stay

  7. Rate of Hospital Mortality [ Time Frame: From hospital admission to 3 months ]
    Mortality during hospital stay

  8. Rate of 90 Days Mortality [ Time Frame: 90 days after randomization ]
    Mortality at 90 days after randomization

  9. Rate of Ventilator Associated Pneumonia [ Time Frame: From start of mechanical ventilation to 2 months ]
    Percentage of participants with lung infection during intensive care unit stay

  10. Rate of Urinary Tract Infection [ Time Frame: From intensive care unit admission to 2 months ]
    Percentage of participants with urinary tract infection during intensive care unit stay

  11. Rate of Bacteremia [ Time Frame: From intensive care unit admission to 2 months ]
    Percentage of participants with blood infection during intensive care unit stay



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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:

  • Medical and surgical ICU patients with 18 years of age or older
  • First episode of mechanical ventilation for more than 24 hours

Exclusion Criteria:

  • Structural neurological disorder
  • Acute toxic-metabolic neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score (GCS) <14 points] at the time of weaning
  • Neuromuscular disease
  • Chronic obstructive pulmonary disease (COPD) receiving NIV
  • Limitation of life support therapy during their admission
  • Tracheostomized patients
  • Spinal cord injuries
  • Scheduled surgical procedure during the 48 hours following extubation
  • Intensive care unit readmission
  • Transfer to another centre
  • Contraindication to non-invasive mechanical ventilation

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): NCT03832387


Locations
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Spain
Hospital General Universitari Castello
Castellón De La Plana, Castello, Spain, 12004
Sponsors and Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators
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Principal Investigator: ALBERTO BELENGUER MUNCHARAZ HOSPITAL GENERAL UNIVERSITARIO CASTELLON

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Responsible Party: Alberto Belenguer, Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT03832387     History of Changes
Other Study ID Numbers: HGCS03
First Posted: February 6, 2019    Key Record Dates
Results First Posted: May 27, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
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
Keywords provided by Alberto Belenguer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:
Non-invasive mechanical ventilation
Oxygen therapy
Extubation failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases