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

Althaia Xarxa Assistencial Universitària de Manresa1 site in 1 country155 target enrollmentMarch 2013

ConditionsRespiratory Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Failure
Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Enrollment: 155
Locations: 1
Primary Endpoint: Respiratory failure after extubation
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

January 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Responsible Party

Principal Investigator

Rafael Fernandez

Head of Intensive Care Department

Althaia Xarxa Assistencial Universitària de Manresa

Eligibility 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.

Outcomes

Primary Outcomes

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')