High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
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ClinicalTrials.gov Identifier: NCT01191489 |
Recruitment Status :
Completed
First Posted : August 30, 2010
Last Update Posted : September 12, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-extubation Respiratory Failure | Device: High Flow Conditioned Oxygen Therapy in High Risk Patients Device: Non-invasive mechanical ventilation Device: Conventional Oxygen Therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1042 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | September 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: High Flow Conditioned Oxygen Therapy in high risk patients |
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula. |
Active Comparator: Non-invasive mechanical ventilation in High Risk Patients |
Device: Non-invasive mechanical ventilation
Bilevel pressure support through a facial mask |
Experimental: High Flow Conditioned Oxygen Therapy in Low Risk Patients |
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
OptiFlow system (R) with nasal cannula. |
Active Comparator: Conventional Oxygen Therapy in Low Risk Patients |
Device: Conventional Oxygen Therapy
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask. |
- Post-extubation respiratory failure and Reintubation rate [ Time Frame: 3 months ]
- Intensive Care Unit mortality rate [ Time Frame: 3 month ]
- Hospital mortality rate [ Time Frame: 6 months ]
- Intensive Care Unit length of stay [ Time Frame: 3 months ]
- Hospital length of stay [ Time Frame: 6 months ]
- Nosocomial pneumonia rate [ Time Frame: 3 months ]
- Tracheobronchitis rate [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191489
Spain | |
Hospital Infanta Sofia | |
San Sebastian de los Reyes, Madrid, Spain, 28703 | |
Hospital General de Ciudad Real | |
Ciudad Real, Spain, 13005 |
Study Chair: | Gonzalo Hernandez, MD | Hospital Infanta Sofia |
Responsible Party: | Gonzalo Hernandez Martinez, Hospital Infanta Sofia |
ClinicalTrials.gov Identifier: | NCT01191489 |
Other Study ID Numbers: |
HULP-3116 |
First Posted: | August 30, 2010 Key Record Dates |
Last Update Posted: | September 12, 2014 |
Last Verified: | September 2014 |
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |