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

Not Applicable

Terminated

• Conditions: Respiratory Failure
• Interventions: Device: Optiflow (Fisher&Paykel); Device: Nasal cannulae or controlled oxygen concentration mask

• Registration Number: NCT01820507
• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-03-28
• Primary Completion: 2014-11
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Conditioned Oxygen Therapy	Optiflow (Fisher&Paykel)	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.
Standard Oxygen Therapy	Nasal cannulae or controlled oxygen concentration mask	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%.

Primary Outcome Measures

Name	Time	Method
Respiratory failure after extubation	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

Name	Time	Method
Survival	90 days

Trial Locations

Locations (1)

ICU. Fundacio Althaia; 🇪🇸 Manresa, Barcelona, Spain