Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy

January 29, 2015 updated by: Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa

Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy

Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named "High flow conditioned oxygen therapy (HFCO)". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Manresa, Barcelona, Spain, 08242
        • ICU. Fundacio Althaia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients mechanically ventilated for > 48 hours and at least one of the following:
  • >65 years
  • cardiac failure as the primary indication of mechanical ventilation
  • Chronic Obstructive Pulmonary Disease
  • Severity score (APACHE II >12 points) the extubation day
  • Body Mass Index >30
  • inability to manage respiratory secretions
  • 1 failed spontaneous breathing trial
  • 1 comorbidity
  • 7 days under mechanical ventilation

Exclusion Criteria:

  • <18 years
  • tracheotomized patients
  • recent facial or cervical trauma/surgery
  • active gastro-intestinal bleeding
  • lack of cooperation
  • patients with any failed spontaneous breathing trial because of hypercapnia development.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Flow Conditioned Oxygen Therapy
Intervention: The Optiflow(R) device supplies oxygen in controlled concentrations and at high flow (from 10 to 70 liters/min) through special nasal cannulae. The device also humidifies the gases mixtures up to 100% relative humidity.
Device: Optiflow (Fisher&Paykel)
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
Other Names:
  • High Flow Conditioned Oxygen Therapy
Active Comparator: Standard Oxygen Therapy
The standard way of oxygen supply after extubation is either by nasal cannulae at flow between 1 and 5 liters/min or by mask with controlled oxygen concentration from 24% to 50%.
Device: Nasal cannulae or controlled oxygen concentration mask
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
Other Names:
  • Standard Oxygen Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory failure after extubation
Time Frame: 72 hours
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Investigators

  • Principal Investigator: Rafael Fernandez, MD, Fundacio Althaia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 12/85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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