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

This study is currently recruiting participants.
Verified September 2012 by Hospital Infanta Sofia
Sponsor:
Information provided by (Responsible Party):
Gonzalo Hernandez Martinez, Hospital Infanta Sofia
ClinicalTrials.gov Identifier:
NCT01191489
First received: August 27, 2010
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Hospital Infanta Sofia:

Primary Outcome Measures:
  • Post-extubation respiratory failure and Reintubation rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensive Care Unit mortality rate [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Hospital mortality rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Intensive Care Unit length of stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nosocomial pneumonia rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Tracheobronchitis rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 990
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191489

Contacts
Contact: Gonzalo Hernandez, MD 0034915275808 ghernandezm@telefonica.net

Locations
Spain
Hospital Infanta Sofia Recruiting
San Sebastian de los Reyes, Madrid, Spain, 28703
Contact: Gonzalo Hernandez, MD    0034915275808    ghernandezm@telefonica.net   
Principal Investigator: Gonzalo Hernandez, MD         
Hospital General de Ciudad Real Not yet recruiting
Ciudad Real, Spain, 13005
Contact: Ramon Ortiz, MD    0034636665996    Ramonortiz1980@hotmail.com   
Principal Investigator: Ramon Ortiz, MD         
Sponsors and Collaborators
Hospital Infanta Sofia
Investigators
Study Chair: Gonzalo Hernandez, MD Hospital Infanta Sofia
  More Information

No publications provided

Responsible Party: Gonzalo Hernandez Martinez, Hospital Infanta Sofia
ClinicalTrials.gov Identifier: NCT01191489     History of Changes
Other Study ID Numbers: HULP-3116
Study First Received: August 27, 2010
Last Updated: September 6, 2012
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on April 21, 2014