Clinical Trial: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.


Detailed Summary:

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.


Sponsor: Dr. Negrin University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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).


Original Secondary Outcome: Same as current

Information By: Dr. Negrin University Hospital

Dates:
Date Received: April 19, 2017
Date Started: May 1, 2017
Date Completion: May 31, 2018
Last Updated: May 12, 2017
Last Verified: May 2017