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Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA)

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ClinicalTrials.gov Identifier: NCT03145974
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Asociación Científica Pulmón y Ventilación Mecánica
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by (Responsible Party):
Jesus Villar, 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.


Condition or disease Intervention/treatment
Acute Respiratory Insufficiency 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
Actual Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA Study)
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Prevalence of hypoxemic acute respiratory failure [ Time Frame: 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 :
  1. death in the hospital [ Time Frame: Hospital stay [Maximum 6 months] ]
    outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145974


Locations
Spain
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 Universitario NS de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital NS del Prado
Talavera de la Reina, Toledo, Spain
Hospital Universitario de La Coruña
A Coruña, Spain
Complejo Hospitalario de Albacete
Albacete, 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 Virgen de Arrixaca
Murcia, Spain
Hospital Universitario Carlos Haya
Málaga, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Rio Hortega - Anesthesia
Valladolid, Spain
Hospital Universitario Rio Hortega
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Sponsors and Collaborators
Dr. Negrin University Hospital
Asociación Científica Pulmón y Ventilación Mecánica
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
Principal Investigator: Jesús Villar, MD, PhD Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain

Responsible Party: Jesus Villar, Clinical scientist, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT03145974     History of Changes
Other Study ID Numbers: ACPVM170501
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jesus Villar, Dr. Negrin University Hospital:
respiratory failure
mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases