NCT03145974

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (actual)
• Sponsor: Dr. Negrin University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	mechanical ventilation	ventilatory support

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-05-09
• Last updated: 2021-03-09

Locations

24 sites across 1 country: Spain