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High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure

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ClinicalTrials.gov Identifier: NCT01191489
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Gonzalo Hernandez Martinez, Hospital Infanta Sofia

Study Description
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Brief Summary:
The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.

Condition or disease Intervention/treatment Phase
Post-extubation Respiratory Failure Device: High Flow Conditioned Oxygen Therapy in High Risk Patients Device: Non-invasive mechanical ventilation Device: Conventional Oxygen Therapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1042 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: High Flow Conditioned Oxygen Therapy in high risk patients Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula.
Active Comparator: Non-invasive mechanical ventilation in High Risk Patients Device: Non-invasive mechanical ventilation
Bilevel pressure support through a facial mask
Experimental: High Flow Conditioned Oxygen Therapy in Low Risk Patients Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula.
Active Comparator: Conventional Oxygen Therapy in Low Risk Patients Device: Conventional Oxygen Therapy
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.


Outcome Measures
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Primary Outcome Measures :
  1. Post-extubation respiratory failure and Reintubation rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Intensive Care Unit mortality rate [ Time Frame: 3 month ]
  2. Hospital mortality rate [ Time Frame: 6 months ]
  3. Intensive Care Unit length of stay [ Time Frame: 3 months ]
  4. Hospital length of stay [ Time Frame: 6 months ]
  5. Nosocomial pneumonia rate [ Time Frame: 3 months ]
  6. Tracheobronchitis rate [ Time Frame: 3 months ]

Eligibility Criteria
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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:

  • Low Risk Patients:
  • Any extubated patients after tolerating a spontaneous breathing trial.
  • High Risk Patients:
  • Any extubated patients after >48 hours under mechanical ventilation and any of the following:

  • >65 years

    • cardiac failure as the primary indication of mechanical ventilation
    • COPD
    • APACHE II >12 points the extubation day
    • BMI >30

    • inability to manage respiratory secretions

      • 1 failed spontaneous breathing trial
      • 1 comorbidity
      • 7 days under mechanical ventilation

Exclusion Criteria:

  • <18 years
  • thacheotomized patients
  • recent facial or cervical trauma/surgery
  • active gastro-intestinal bleeding
  • lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.
Contacts and Locations
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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): NCT01191489


Locations
Spain
Hospital Infanta Sofia
San Sebastian de los Reyes, Madrid, Spain, 28703
Hospital General de Ciudad Real
Ciudad Real, Spain, 13005
Sponsors and Collaborators
Hospital Infanta Sofia
Investigators
Study Chair: Gonzalo Hernandez, MD Hospital Infanta Sofia
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gonzalo Hernandez Martinez, Hospital Infanta Sofia
ClinicalTrials.gov Identifier: NCT01191489     History of Changes
Other Study ID Numbers: HULP-3116
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases