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NCT Number: NCT03145974

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario de Santiago, Santiago de Compostela, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical ventilation

Device

ventilatory support

Primary outcomes

  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 outcomes

  1. death in the ICU

    Time frame: Intensive care unit stay [up to 60 days]

    outcome at the time of discharge from ICU

  2. 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).

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • Asociación Científica Pulmón y Ventilación Mecánica
  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

Registry information

Official study title

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

Acronym: PANDORA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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