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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Conditioned Oxygen Therapy in high risk patients | Experimental |
| |
| Non-invasive mechanical ventilation in High Risk Patients | Active Comparator |
| |
| High Flow Conditioned Oxygen Therapy in Low Risk Patients | Experimental |
| |
| Conventional Oxygen Therapy in Low Risk Patients | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Conditioned Oxygen Therapy in High Risk Patients | Device | OptiFlow system (R) with nasal cannula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-extubation respiratory failure and Reintubation rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit mortality rate | 3 month | |
| Hospital mortality rate | 6 months | |
| Intensive Care Unit length of stay |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Hernandez, MD | Hospital Infanta Sofia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Ciudad Real | Ciudad Real | Ciudad Real | 13005 | Spain | ||
| Hospital Infanta Sofia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39774863 | Derived | Rodriguez Villamizar P, Thille AW, Marquez Doblas M, Frat JP, Leal Sanz P, Alonso E, Pais V, Morales G, Colinas L, Propin A, Fernandez Olivares A, Martinez Balaguer M, Alvaredo Rodrigo D, Hernandez G. Best clinical model predicting extubation failure: a diagnostic accuracy post hoc analysis. Intensive Care Med. 2025 Jan;51(1):106-114. doi: 10.1007/s00134-024-07758-0. Epub 2025 Jan 7. | |
| 27706464 |
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| Non-invasive mechanical ventilation | Device | Bilevel pressure support through a facial mask |
|
| Conventional Oxygen Therapy | Device | Conventional Oxygen Therapy with nasal cannula or Venturi facial mask. |
|
| 3 months |
| Hospital length of stay | 6 months |
| Nosocomial pneumonia rate | 3 months |
| Tracheobronchitis rate | 3 months |
| San Sebastián de los Reyes |
| Madrid |
| 28703 |
| Spain |
| Derived |
| 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. |
| 26975498 | Derived | 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. |
| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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