Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

Completed

• Conditions: Acute Respiratory Insufficiency
• Interventions: Device: mechanical ventilation

• Registration Number: NCT03145974
• Lead Sponsor: Dr. Negrin University Hospital

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 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.

Study Timeline

• Study First Submitted: 2017-04-19
• Study Start: 2017-05-01
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-07
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• 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.

Exclusion Criteria

• No patients should be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypoxemic Acute Respiratory Failure	mechanical ventilation	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of hypoxemic acute respiratory failure	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.

Secondary Outcome Measures

Name	Time	Method
death in the hospital	Hospital stay [Maximum 6 months]	outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure).
death in the ICU	Intensive care unit stay [up to 60 days]	outcome at the time of discharge from ICU

Trial Locations

Locations (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 NS del Prado; 🇪🇸 Talavera de la Reina, Toledo, Spain

Hospital Universitario Rio Hortega; 🇪🇸 Valladolid, Spain

Hospital Universitario NS de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Tenerife, Spain

Hospital Universitario de La Coruña; 🇪🇸 A Coruña, Spain

Complejo Hospitalario Universitario de León; 🇪🇸 León, Spain

Hospital Virgen de La Luz; 🇪🇸 Cuenca, Spain

Hospital Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Complejo Hospitalario de Albacete; 🇪🇸 Albacete, Spain

Hospital General de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de Arrixaca; 🇪🇸 Murcia, Spain

Hospital General de Segovia; 🇪🇸 Segovia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Rio Hortega - Anesthesia; 🇪🇸 Valladolid, Spain

Hospital Virgen de la Concha; 🇪🇸 Zamora, Spain