Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales

Acute Respiratory Insufficiency Clinical Trial

— PANDORAWALES  

Official title:

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358043
• Other study ID #: ACPVM170916
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2019
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• mechanical ventilation
Consecutive intubated pateints receiving mechanical ventilation with a PaO2/FiO2=300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	Asociación Científica Pulmón y Ventilación Mecánica, Consorcio Centro de Investigación Biomédica en Red, M.P.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death in the hospital	outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure)	Hospital stay (maximum 6 months)