Prevalence and Outcome of Acute Hypoxemic Respiratory Failure
NCT ID: NCT03145974
Last Updated: 2021-03-09
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
1400 participants
OBSERVATIONAL
2017-05-01
2018-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
mechanical ventilation
ventilatory support
Interventions
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mechanical ventilation
ventilatory support
Eligibility Criteria
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Inclusion Criteria
* Endotracheal intubation and mechanical ventilation, independent of whether the need for ventilatory support is shorter or longer than 24 hours. Only patients receiving invasive mechanical ventilation can be included, although patients could have been on non-invasive ventilation before intubation.
* PaO2/FiO2 ≤300 mmHg on invasive mechanical ventilation with a PEEP of 5 cmH2O or more, and with a FiO2 of 0.3 or more.
18 Years
ALL
No
Sponsors
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Asociación Científica Pulmón y Ventilación Mecánica
OTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Dr. Negrin University Hospital
OTHER
Responsible Party
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Jesus Villar
Clinical scientist
Principal Investigators
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Jesús Villar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
Locations
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Complejo Hospitalario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Mutua de Terrasa
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
Countries
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References
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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.
Other Identifiers
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ACPVM170501
Identifier Type: -
Identifier Source: org_study_id
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