Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Insufficiency
• Intervention / Treatment: Device: mechanical ventilation

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 Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain
    • Hospital Universitario de La Coruña
  • Albacete, Spain
    • Complejo Hospitalario de Albacete
  • Ciudad Real, Spain
    • Hospital General de Ciudad Real
  • Cuenca, Spain
    • Hospital Virgen De La Luz
  • León, Spain
    • Complejo Hospitalario Universitario de León
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain
    • Hospital Fundación Jiménez Díaz
  • Murcia, Spain
    • Hospital Universitario Virgen de Arrixaca
  • Málaga, Spain
    • Hospital Universitario Carlos Haya
  • Segovia, Spain
    • Hospital General de Segovia
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia
  • Valladolid, Spain
    • Hospital Clínico Universitario de Valladolid
  • Valladolid, Spain
    • Hospital Universitario Río Hortega
  • Valladolid, Spain
    • Hospital Universitario Rio Hortega - Anesthesia
  • Zamora, Spain
    • Hospital Virgen de la Concha
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain
      • Complejo Hospitalario de Santiago
  • Barcelona
    • Terrassa, Barcelona, Spain
      • Hospital Universitario Mutua de Terrasa
  • Ciudad Real
    • Alcázar de San Juan, Ciudad Real, Spain
      • Hospital La Mancha Centro
  • León
    • Ponferrada, León, Spain
      • Hospital El Bierzo
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain
      • Hospital Universitario NS de Candelaria
  • Toledo
    • Talavera de la Reina, Toledo, Spain
      • Hospital NS del Prado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: mechanical ventilation; ventilatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital
• Collaborators: Asociación Científica Pulmón y Ventilación Mecánica; Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Investigators: Principal Investigator: Jesús Villar, MD, PhD, Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: mechanical ventilation; respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ACPVM170501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients' data will be anonymized and recorded in a case report form (CRF) specifically designed for this study. Data will be presented globally at the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No