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

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.

Study Overview

• Status: Completed
• Conditions: Post-extubation Respiratory Failure
• Intervention / Treatment: Device: High Flow Conditioned Oxygen Therapy in High Risk Patients; Device: Non-invasive mechanical ventilation; Device: Conventional Oxygen Therapy

• Study Type: Interventional
• Enrollment (Actual): 1042
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real, Spain, 13005
    • Hospital General de Ciudad Real
  • Madrid
    • San Sebastian de los Reyes, Madrid, Spain, 28703
      • Hospital Infanta Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Flow Conditioned Oxygen Therapy in high risk patients	Device: High Flow Conditioned Oxygen Therapy in High Risk Patients; OptiFlow system (R) with nasal cannula.
Active Comparator: Non-invasive mechanical ventilation in High Risk Patients	Device: Non-invasive mechanical ventilation; Bilevel pressure support through a facial mask
Experimental: High Flow Conditioned Oxygen Therapy in Low Risk Patients	Device: High Flow Conditioned Oxygen Therapy in High Risk Patients; OptiFlow system (R) with nasal cannula.
Active Comparator: Conventional Oxygen Therapy in Low Risk Patients	Device: Conventional Oxygen Therapy; Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Infanta Sofia
• Investigators: Study Chair: Gonzalo Hernandez, MD, Hospital Infanta Sofía

Publications and helpful links

General Publications

• Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.
• Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HULP-3116