Clinical trial NCT03145974: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure
Official title: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Insufficiency
Keywords: respiratory failure
mechanical ventilation
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: Asociación Científica Pulmón y Ventilación Mecánica
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2017-05-09
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of hypoxemic acute respiratory failure
timeFrame: 6 months
Secondary outcomes:
measure: death in the ICU
timeFrame: Intensive care unit stay [up to 60 days]
measure: death in the hospital
timeFrame: Hospital stay [Maximum 6 months]
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario de Santiago
state: A Coruña
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrasa
state: Barcelona
city: Alcázar de San Juan
country: Spain
facility: Hospital La Mancha Centro
state: Ciudad Real
city: Ponferrada
country: Spain
facility: Hospital El Bierzo
state: León
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario NS de Candelaria
state: Tenerife
city: Talavera de la Reina
country: Spain
facility: Hospital NS del Prado
state: Toledo
city: A Coruña
country: Spain
facility: Hospital Universitario de La Coruña
city: Albacete
country: Spain
facility: Complejo Hospitalario de Albacete
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Cuenca
country: Spain
facility: Hospital Virgen de La Luz
city: León
country: Spain
facility: Complejo Hospitalario Universitario de León
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega - Anesthesia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
Study officials:
affiliation: Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain
name: Jesús Villar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.