We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Slow recruitment, interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820507
First Posted: March 28, 2013
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
  Purpose
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.

Condition Intervention
Respiratory Failure Device: Optiflow (Fisher&Paykel) Device: Nasal cannulae or controlled oxygen concentration mask

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy

Resource links provided by NLM:


Further study details as provided by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa:

Primary Outcome Measures:
  • 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')


Secondary Outcome Measures:
  • Survival [ Time Frame: 90 days ]

Enrollment: 155
Study Start Date: March 2013
Study Completion Date: January 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Standard Oxygen Therapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820507


Locations
Spain
ICU. Fundacio Althaia
Manresa, Barcelona, Spain, 08242
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
Principal Investigator: Rafael Fernandez, MD Fundacio Althaia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rafael Fernandez, Head of Intensive Care Department, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier: NCT01820507     History of Changes
Other Study ID Numbers: CEIC 12/85
First Submitted: March 26, 2013
First Posted: March 28, 2013
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa:
Post-extubation respiratory failure
Endotracheal intubation
Mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases