Clinical trial NCT03358043: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales
Official title: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Insufficiency
Keywords: respiratory failure
mechanical ventilation
prevalence
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: 2017-11-30
Enrollment: 1100
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 will be enrolled into the study.

Brief summary: This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from Wales (U.K.).

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 hospitals from Wales (U.K.). 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. This study will be done simultaneously with the PANDORA (NCT03145974) in Spain.

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 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 shhould 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: 4 months
Secondary outcomes:
measure: Death in the hospital
timeFrame: Hospital stay (maximum 6 months)
Other outcomes:
Locations:
city: Abergavenny
country: United Kingdom
facility: Nevill Hall Hospital
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Carmarthen
country: United Kingdom
facility: Glangwili General Hospital
city: Haverfordwest
country: United Kingdom
facility: Withybush General Hospital
city: Llantrisant
country: United Kingdom
facility: Royal Glamorgan Hospital
city: Merthyr Tydfil
country: United Kingdom
facility: Prince Charles Hospital
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: Rhyl
country: United Kingdom
facility: Ysbyty Glan Clwyd
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
affiliation: Clinical Scientist
name: Jesús Villar, MD
role: STUDY_CHAIR
affiliation: Clinical Scientist
name: Robert M Kacmarek, PhD
role: STUDY_CHAIR
References: