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

Althaia Xarxa Assistencial Universitària de Manresa

Status: Terminated

Conditions: Respiratory Failure

Treatments: Device: Nasal cannulae or controlled oxygen concentration mask; Device: Optiflow (Fisher&Paykel)

Study type: Interventional

Funder types: Other

Identifiers

NCT01820507

CEIC 12/85

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 2 patient groups

High Flow Conditioned Oxygen Therapy

Experimental group

Description:

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.

Treatment:

Device: Optiflow (Fisher&Paykel)

Standard Oxygen Therapy

Active Comparator group

Description:

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%.

Treatment:

Device: Nasal cannulae or controlled oxygen concentration mask