Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales (PANDORAWALES)

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.).

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 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.

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• United Kingdom
  • Abergavenny, United Kingdom
    • Nevill Hall Hospital
  • Bangor, United Kingdom
    • Ysbyty Gwynedd
  • Cardiff, United Kingdom
    • University Hospital of Wales
  • Cardiff, United Kingdom
    • Cardiff University
  • Carmarthen, United Kingdom
    • Glangwili General Hospital
  • Haverfordwest, United Kingdom
    • Withybush General Hospital
  • Llantrisant, United Kingdom
    • Royal Glamorgan Hospital
  • Merthyr Tydfil, United Kingdom
    • Prince Charles Hospital
  • Newport, United Kingdom
    • Royal Gwent Hospital
  • Rhyl, United Kingdom
    • Ysbyty Glan Clwyd
  • Swansea, United Kingdom
    • Morriston Hospital
  • Wrexham, United Kingdom
    • Wrexham Maelor Hospital

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 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 shhould 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?

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; (ii) total number of mechanically ventilated patients during the study period; and (iii) per ICU bed available over the study period.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Consorcio Centro de Investigación Biomédica en Red, M.P.; Asociación Científica Pulmón y Ventilación Mecánica
• Investigators: Study Chair: Jesús Villar, MD, Clinical Scientist; Study Chair: Robert M Kacmarek, PhD, Clinical Scientist

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; prevalence; respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ACPVM170916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data from all patients must be collected and pooled by the coordinating center (Dr. Tamas Szakmany, All Wales Critical Care and Trauma Network)

Drug and device information, study documents

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