NCT01191489

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

Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,042 (actual)
• Sponsor: Hospital Infanta Sofia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-extubation Respiratory Failure

Interventions

Type	Name	Description
DEVICE	High Flow Conditioned Oxygen Therapy in High Risk Patients	OptiFlow system (R) with nasal cannula.
DEVICE	Non-invasive mechanical ventilation	Bilevel pressure support through a facial mask
DEVICE	Conventional Oxygen Therapy	Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2010-08-30
• Last updated: 2014-09-12

Locations

2 sites across 1 country: Spain