Status:
COMPLETED
High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
Lead Sponsor:
Hospital Infanta Sofia
Conditions:
Post-extubation Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hi...
Eligibility Criteria
Inclusion
- 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
- \<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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1042 Patients enrolled
Trial Details
Trial ID
NCT01191489
Start Date
September 1 2012
End Date
September 1 2014
Last Update
September 12 2014
Active Locations (2)
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1
Hospital General de Ciudad Real
Ciudad Real, Ciudad Real, Spain, 13005
2
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain, 28703