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

NCT01191489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1042

Last updated 2014-09-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital Infanta Sofia

    lead OTHER

Principal Investigators

  • Gonzalo Hernandez, MD · Hospital Infanta Sofia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191489 on ClinicalTrials.gov