Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

Acute Respiratory Insufficiency Clinical Trial

— PANDORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145974
• Other study ID #: ACPVM170501
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• mechanical ventilation
ventilatory support

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Coruña	A Coruña
Spain	Complejo Hospitalario de Albacete	Albacete
Spain	Hospital La Mancha Centro	Alcázar de San Juan	Ciudad Real
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 El Bierzo	Ponferrada	León
Spain	Hospital Universitario NS de Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Complejo Hospitalario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital General de Segovia	Segovia
Spain	Hospital NS del Prado	Talavera de la Reina	Toledo
Spain	Hospital Universitario Mutua de Terrasa	Terrassa	Barcelona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Rio Hortega	Valladolid
Spain	Hospital Universitario Rio Hortega - Anesthesia	Valladolid
Spain	Hospital Virgen de la Concha	Zamora

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	Asociación Científica Pulmón y Ventilación Mecánica, Consorcio Centro de Investigación Biomédica en Red, M.P.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	death in the ICU	outcome at the time of discharge from ICU	Intensive care unit stay [up to 60 days]
Secondary	death in the hospital	outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure).	Hospital stay [Maximum 6 months]