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The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conditioned NIV in High Risk Patients | Experimental |
| |
| HFOT in High Risk Patients | Active Comparator |
| |
| Conditioned NIV in Obese Intermediate Risk Patients | Experimental |
| |
| HFOT in Obese Intermediate Risk Patient | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive Conditioned NIV Therapy after planned extubation | Device | Conditioned NIV during 48 hours following extubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation rate | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit mortality rate | 3 months | |
| Hospital mortality rate | 3 months | |
| Intensive Care Unit length of stay |
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Inclusion Criteria:
High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index >30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Hernandez | SESCAM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de la Salud | Toledo | Castille-La Mancha | 45007 | Spain | ||
| La princesa University Hospital |
| 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. | |
| 39514845 |
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| Preventive HFOT after planned extubation | Device | HFOT set according to patients tolerance during 48 hours following extubation |
|
| 3 months |
| Hospital length of stay | 6 months |
| Respiratory infection rate | 6 months |
| Madrid |
| 28006 |
| Spain |
| Derived |
| Hernandez G, Dianti J, Paredes I, Moran F, Marquez M, Calle A, Colinas L, Alonso G, Carneiro P, Morales G, Suarez-Sipmann F, Canabal A, Goligher E, Roca O. Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):222-229. doi: 10.1164/rccm.202403-0523OC. |
| 36400984 | Derived | Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18. |