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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191489

Enrollment

1042

Registered

2010-08-30

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-extubation Respiratory Failure

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.

Interventions

DEVICEHigh Flow Conditioned Oxygen Therapy in High Risk Patients

OptiFlow system (R) with nasal cannula.

DEVICENon-invasive mechanical ventilation

Bilevel pressure support through a facial mask

DEVICEConventional Oxygen Therapy

Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Post-extubation respiratory failure and Reintubation rate	3 months

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026