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| Name | Class |
|---|---|
| Asociación Científica Pulmón y Ventilación Mecánica | OTHER |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
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This study is an extension of the Spanish Initiative for Epidemiology, Stratification and Therapies of Acute respiratory failure (SIESTA) Network.
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more, and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals.
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of adult mechanically ventilated patients with acute hypoxemic respiratory failure [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals. Although there are few previous published observational studies examining the incidence and mortality of patients with acute respiratory failure and ARDS, there are no studies specifically assessing the epidemiological characteristics, patterns of ventilation and clinical outcomes in patients with acute hypoxemic respiratory failure in the current era of lung protective ventilation.
Since the study is prospective, with consecutive collection of clinically relevant data from patients and with the participation of several ICUs from different geographical regions of Spain, the findings would be highly generalizable. The study is aimed to improve the knowledge on the epidemiology and outcome of ventilated patients, to identify the percentage of patients developing ARDS under the current definition, to validate a bedside scoring system developed by us for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoxemic Acute Respiratory Failure | Consecutive intubated patients receiving invasive mechanical ventilation, with a PaO2/FiO2 ≤300 mmHg under a PEEP of 5 cmH2O or more, and with a FiO2 of 0.3 or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical ventilation | Device | ventilatory support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hypoxemic acute respiratory failure | The investigators will calculate the prevalence in relation to: (i) total number of ICU admissions during the study period in all participating centers; (ii) total number of mechanically ventilated patients during the study period in all participating centers, and (iii) per ICU bed available in the participating centers over the study period. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| death in the ICU | outcome at the time of discharge from ICU | Intensive care unit stay [up to 60 days] |
| death in the hospital | outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure). |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients admitted to participating ICUs will be screened daily. Only patients meeting inclusion criteria for acute hypoxemic respiratory failure (as defined above) will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jesús Villar, MD, PhD | Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario de Santiago | Santiago de Compostela | A Coruña | Spain | |||
| Hospital Universitario Mutua de Terrasa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34259448 | Derived | Villar J, Gonzalez-Martin JM, Ambros A, Mosteiro F, Martinez D, Fernandez L, Soler JA, Parra L, Solano R, Soro M, Del Campo R, Gonzalez-Luengo RI, Civantos B, Montiel R, Pita-Garcia L, Vidal A, Anon JM, Ferrando C, Diaz-Dominguez FJ, Mora-Ordonez JM, Fernandez MM, Fernandez C, Fernandez RL, Rodriguez-Suarez P, Steyerberg EW, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score. Crit Care Med. 2021 Oct 1;49(10):e920-e930. doi: 10.1097/CCM.0000000000005142. |
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Patients' data will be anonymized and recorded in a case report form (CRF) specifically designed for this study. Data will be presented globally at the end of the study
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| Hospital stay [Maximum 6 months] |
| Terrassa |
| Barcelona |
| Spain |
| Hospital La Mancha Centro | Alcázar de San Juan | Ciudad Real | Spain |
| Hospital El Bierzo | Ponferrada | León | Spain |
| Hospital Universitario NS de Candelaria | Santa Cruz de Tenerife | Tenerife | Spain |
| Hospital NS del Prado | Talavera de la Reina | Toledo | Spain |
| Hospital Universitario de La Coruña | A Coruña | Spain |
| Complejo Hospitalario de Albacete | Albacete | Spain |
| Hospital General de Ciudad Real | Ciudad Real | Spain |
| Hospital Virgen de La Luz | Cuenca | Spain |
| Complejo Hospitalario Universitario de León | León | Spain |
| Hospital Fundación Jiménez Díaz | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Carlos Haya | Málaga | Spain |
| Hospital Universitario Virgen de Arrixaca | Murcia | Spain |
| Hospital General de Segovia | Segovia | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain |
| Hospital Universitario Rio Hortega - Anesthesia | Valladolid | Spain |
| Hospital Universitario Rio Hortega | Valladolid | Spain |
| Hospital Virgen de la Concha | Zamora | Spain |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D012138 | Respiratory Therapy |
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