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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014