Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

NCT ID: NCT03145974

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-31

Brief Summary

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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

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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

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Acute Respiratory Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypoxemic Acute Respiratory Failure

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.

mechanical ventilation

Intervention Type DEVICE

ventilatory support

Interventions

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mechanical ventilation

ventilatory support

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación Científica Pulmón y Ventilación Mecánica

OTHER

Sponsor Role collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesus Villar

Clinical scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesús Villar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain

Locations

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Complejo Hospitalario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital Universitario Mutua de Terrasa

Terrassa, Barcelona, Spain

Site Status

Hospital La Mancha Centro

Alcázar de San Juan, Ciudad Real, Spain

Site Status

Hospital El Bierzo

Ponferrada, León, Spain

Site Status

Hospital Universitario NS de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Hospital NS del Prado

Talavera de la Reina, Toledo, Spain

Site Status

Hospital Universitario de La Coruña

A Coruña, , Spain

Site Status

Complejo Hospitalario de Albacete

Albacete, , Spain

Site Status

Hospital General de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Virgen de La Luz

Cuenca, , Spain

Site Status

Complejo Hospitalario Universitario de León

León, , Spain

Site Status

Hospital Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Carlos Haya

Málaga, , Spain

Site Status

Hospital Universitario Virgen de Arrixaca

Murcia, , Spain

Site Status

Hospital General de Segovia

Segovia, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Hospital Universitario Rio Hortega - Anesthesia

Valladolid, , Spain

Site Status

Hospital Universitario Rio Hortega

Valladolid, , Spain

Site Status

Hospital Virgen de la Concha

Zamora, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 34259448 (View on PubMed)

Other Identifiers

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ACPVM170501

Identifier Type: -

Identifier Source: org_study_id

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