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

Phase 3

Completed

• Conditions: Post-extubation Respiratory Failure
• Interventions: Device: Non-invasive mechanical ventilation; Device: High Flow Conditioned Oxygen Therapy in High Risk Patients; Device: Conventional Oxygen Therapy

• Registration Number: NCT01191489
• Lead Sponsor: Hospital Infanta Sofia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2012-09
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1042

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive mechanical ventilation in High Risk Patients	Non-invasive mechanical ventilation	-
High Flow Conditioned Oxygen Therapy in Low Risk Patients	High Flow Conditioned Oxygen Therapy in High Risk Patients	-
High Flow Conditioned Oxygen Therapy in high risk patients	High Flow Conditioned Oxygen Therapy in High Risk Patients	-
Conventional Oxygen Therapy in Low Risk Patients	Conventional Oxygen Therapy	-

Primary Outcome Measures

Name	Time	Method
Post-extubation respiratory failure and Reintubation rate	3 months

Secondary Outcome Measures

Name	Time	Method
Intensive Care Unit mortality rate	3 month
Hospital mortality rate	6 months
Intensive Care Unit length of stay	3 months
Hospital length of stay	6 months
Nosocomial pneumonia rate	3 months
Tracheobronchitis rate	3 months

Trial Locations

Locations (2)

Hospital Infanta Sofia; 🇪🇸 San Sebastian de los Reyes, Madrid, Spain

Hospital General de Ciudad Real; 🇪🇸 Ciudad Real, Spain