Prevalence and Outcome of Acute Hypoxemic Respiratory Failure
PANDORA
1 other identifier
observational
1,400
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedMarch 9, 2021
July 1, 2018
1.1 years
April 19, 2017
March 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
death in the ICU
Intensive care unit stay [up to 60 days]
death in the hospital
Hospital stay [Maximum 6 months]
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Age ≥18-year old.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
Related Publications (1)
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.
PMID: 34259448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesús Villar, MD, PhD
Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical scientist
Study Record Dates
First Submitted
April 19, 2017
First Posted
May 9, 2017
Study Start
May 1, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
March 9, 2021
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share
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