Clinical trial NCT01191489: High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
Official title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-extubation Respiratory Failure
Lead sponsor: Hospital Infanta Sofia
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 1042
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.


Eligibility criteria: Inclusion Criteria:

* Low Risk Patients:
* Any extubated patients after tolerating a spontaneous breathing trial.
* High Risk Patients:
* Any extubated patients after \>48 hours under mechanical ventilation and any of the following:
* \>65 years

  * cardiac failure as the primary indication of mechanical ventilation
  * COPD
  * APACHE II \>12 points the extubation day
  * BMI \>30
  * inability to manage respiratory secretions

    * 1 failed spontaneous breathing trial
    * 1 comorbidity
    * 7 days under mechanical ventilation

Exclusion Criteria:

* \<18 years
* thacheotomized patients
* recent facial or cervical trauma/surgery
* active gastro-intestinal bleeding
* lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.

Primary outcomes:
measure: Post-extubation respiratory failure and Reintubation rate
timeFrame: 3 months
Secondary outcomes:
measure: Intensive Care Unit mortality rate
timeFrame: 3 month
measure: Hospital mortality rate
timeFrame: 6 months
measure: Intensive Care Unit length of stay
timeFrame: 3 months
measure: Hospital length of stay
timeFrame: 6 months
measure: Nosocomial pneumonia rate
timeFrame: 3 months
measure: Tracheobronchitis rate
timeFrame: 3 months
Other outcomes:
Locations:
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofia
state: Madrid
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
Study officials:
affiliation: Hospital Infanta Sofia
name: Gonzalo Hernandez, MD
role: STUDY_CHAIR
References:
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
citation: Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.