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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820507
• Other study ID #: CEIC 12/85
• Status: Terminated
• Phase: N/A
• First received: March 26, 2013
• Last updated: January 29, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Optiflow (Fisher&Paykel)
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
• Nasal cannulae or controlled oxygen concentration mask
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.

Locations

Country	Name	City	State
Spain	ICU. Fundacio Althaia	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory failure after extubation	Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')	72 hours	Yes
Secondary	Survival		90 days	Yes