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

Post-extubation Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191489
• Other study ID #: HULP-3116
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2010
• Last updated: September 10, 2014
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Hospital Infanta Sofia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-extubation Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Infanta Sofia	San Sebastian de los Reyes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infanta Sofia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-extubation respiratory failure and Reintubation rate		3 months	No
Secondary	Intensive Care Unit mortality rate		3 month	No
Secondary	Hospital mortality rate		6 months	No
Secondary	Intensive Care Unit length of stay		3 months	No
Secondary	Hospital length of stay		6 months	No
Secondary	Nosocomial pneumonia rate		3 months	No
Secondary	Tracheobronchitis rate		3 months	No