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

Primary Purpose

Post-extubation Respiratory Failure

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
High Flow Conditioned Oxygen Therapy in High Risk Patients
Non-invasive mechanical ventilation
Conventional Oxygen Therapy
Sponsored by
Hospital Infanta Sofia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-extubation Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Infanta Sofia
  • Hospital General de Ciudad Real

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

High Flow Conditioned Oxygen Therapy in high risk patients

Non-invasive mechanical ventilation in High Risk Patients

High Flow Conditioned Oxygen Therapy in Low Risk Patients

Conventional Oxygen Therapy in Low Risk Patients

Arm Description

Outcomes

Primary Outcome Measures

Post-extubation respiratory failure and Reintubation rate

Secondary Outcome Measures

Intensive Care Unit mortality rate
Hospital mortality rate
Intensive Care Unit length of stay
Hospital length of stay
Nosocomial pneumonia rate
Tracheobronchitis rate

Full Information

First Posted
August 27, 2010
Last Updated
September 10, 2014
Sponsor
Hospital Infanta Sofia
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1. Study Identification

Unique Protocol Identification Number
NCT01191489
Brief Title
High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
Official Title
Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infanta Sofia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-extubation Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1042 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Conditioned Oxygen Therapy in high risk patients
Arm Type
Experimental
Arm Title
Non-invasive mechanical ventilation in High Risk Patients
Arm Type
Active Comparator
Arm Title
High Flow Conditioned Oxygen Therapy in Low Risk Patients
Arm Type
Experimental
Arm Title
Conventional Oxygen Therapy in Low Risk Patients
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High Flow Conditioned Oxygen Therapy in High Risk Patients
Intervention Description
OptiFlow system (R) with nasal cannula.
Intervention Type
Device
Intervention Name(s)
Non-invasive mechanical ventilation
Intervention Description
Bilevel pressure support through a facial mask
Intervention Type
Device
Intervention Name(s)
Conventional Oxygen Therapy
Intervention Description
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
Primary Outcome Measure Information:
Title
Post-extubation respiratory failure and Reintubation rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intensive Care Unit mortality rate
Time Frame
3 month
Title
Hospital mortality rate
Time Frame
6 months
Title
Intensive Care Unit length of stay
Time Frame
3 months
Title
Hospital length of stay
Time Frame
6 months
Title
Nosocomial pneumonia rate
Time Frame
3 months
Title
Tracheobronchitis rate
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Hernandez, MD
Organizational Affiliation
Hospital Infanta Sofia
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Infanta Sofia
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28703
Country
Spain
Facility Name
Hospital General de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27706464
Citation
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.
Results Reference
derived
PubMed Identifier
26975498
Citation
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.
Results Reference
derived

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

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