NCT01191489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,042

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

August 27, 2010

Last Update Submit

September 10, 2014

Conditions

Post-extubation Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Post-extubation respiratory failure and Reintubation rate

    3 months

Secondary Outcomes (6)

  • Intensive Care Unit mortality rate

    3 month

  • Hospital mortality rate

    6 months

  • Intensive Care Unit length of stay

    3 months

  • Hospital length of stay

    6 months

  • Nosocomial pneumonia rate

    3 months

  • +1 more secondary outcomes

Study Arms (4)

High Flow Conditioned Oxygen Therapy in high risk patients

EXPERIMENTAL
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients

Non-invasive mechanical ventilation in High Risk Patients

ACTIVE COMPARATOR
Device: Non-invasive mechanical ventilation

High Flow Conditioned Oxygen Therapy in Low Risk Patients

EXPERIMENTAL
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients

Conventional Oxygen Therapy in Low Risk Patients

ACTIVE COMPARATOR
Device: Conventional Oxygen Therapy

Interventions

High Flow Conditioned Oxygen Therapy in High Risk PatientsDEVICE

OptiFlow system (R) with nasal cannula.

High Flow Conditioned Oxygen Therapy in Low Risk PatientsHigh Flow Conditioned Oxygen Therapy in high risk patients
Non-invasive mechanical ventilationDEVICE

Bilevel pressure support through a facial mask

Non-invasive mechanical ventilation in High Risk Patients
Conventional Oxygen TherapyDEVICE

Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.

Conventional Oxygen Therapy in Low Risk Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • failed spontaneous breathing trial
  • comorbidity
  • days under mechanical ventilation

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital General de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

Location

Hospital Infanta Sofia

San Sebastián de los Reyes, Madrid, 28703, Spain

Location

Related Publications (2)

  • 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.

    PMID: 27706464DERIVED

  • 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.

    PMID: 26975498DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Gonzalo Hernandez, MD

    Hospital Infanta Sofia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gonzalo Hernandez Martinez

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

ES(2)