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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820507

Enrollment

155

Registered

2013-03-28

Start date

2013-03-31

Completion date

2015-01-31

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation

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.

Interventions

DEVICEOptiflow (Fisher&Paykel)

The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.

DEVICENasal cannulae or controlled oxygen concentration mask

The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Survival	90 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026