High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
NCT ID: NCT01191489
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1042 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Flow Conditioned Oxygen Therapy in high risk patients
High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula.
Non-invasive mechanical ventilation in High Risk Patients
Non-invasive mechanical ventilation
Bilevel pressure support through a facial mask
High Flow Conditioned Oxygen Therapy in Low Risk Patients
High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula.
Conventional Oxygen Therapy in Low Risk Patients
Conventional Oxygen Therapy
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
Interventions
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High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula.
Non-invasive mechanical ventilation
Bilevel pressure support through a facial mask
Conventional Oxygen Therapy
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital Infanta Sofia
OTHER
Responsible Party
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Gonzalo Hernandez Martinez
Gonzalo Hernandez Martinez
Principal Investigators
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Gonzalo Hernandez, MD
Role: STUDY_CHAIR
Hospital Infanta Sofia
Locations
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Hospital General de Ciudad Real
Ciudad Real, Ciudad Real, Spain
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Countries
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References
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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.
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.
Other Identifiers
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HULP-3116
Identifier Type: -
Identifier Source: org_study_id
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