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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Althaia Xarxa Assistencial Universitària de Manresa
Sponsor:
Information provided by (Responsible Party):
Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier:
NCT01820507
First received: March 26, 2013
Last updated: November 28, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Althaia Xarxa Assistencial Universitària de Manresa:

Primary Outcome Measures:
  • Respiratory failure after extubation [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820507

Locations
Spain
ICU. Fundacio Althaia Recruiting
Manresa, Barcelona, Spain, 08242
Contact: Rafael Fernandez, MD    34.938732112 ext 3216    rfernandezf@althaia.cat   
Principal Investigator: Rafael Fernandez, MD         
Sub-Investigator: Carles Subira, MD         
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
Principal Investigator: Rafael Fernandez, MD Fundacio Althaia
  More Information

No publications provided

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
Study First Received: March 26, 2013
Last Updated: November 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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

ClinicalTrials.gov processed this record on October 23, 2014