Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA)
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|ClinicalTrials.gov Identifier: NCT03145974|
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : August 2, 2018
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.
|Condition or disease||Intervention/treatment|
|Acute Respiratory Insufficiency||Device: mechanical ventilation|
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.
|Study Type :||Observational|
|Actual Enrollment :||1400 participants|
|Official Title:||Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA Study)|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||May 31, 2018|
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.
Device: mechanical ventilation
- Prevalence of hypoxemic acute respiratory failure [ Time Frame: 6 months ]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.
- death in the hospital [ Time Frame: Hospital stay [Maximum 6 months] ]outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure).
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): NCT03145974
|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|
|Hospital General de Ciudad Real|
|Ciudad Real, Spain|
|Hospital Virgen de La Luz|
|Complejo Hospitalario Universitario de León|
|Hospital Fundación Jiménez Díaz|
|Hospital Universitario 12 de Octubre|
|Hospital Universitario La Paz|
|Hospital Universitario Puerta de Hierro|
|Hospital Universitario Ramón y Cajal|
|Hospital Universitario Virgen de Arrixaca|
|Hospital Universitario Carlos Haya|
|Hospital General de Segovia|
|Hospital Clínico Universitario de Valencia|
|Hospital Clínico Universitario de Valladolid|
|Hospital Universitario Rio Hortega - Anesthesia|
|Hospital Universitario Rio Hortega|
|Hospital Virgen de la Concha|
|Principal Investigator:||Jesús Villar, MD, PhD||Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain|