Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales

NCT ID: NCT03358043

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ventilatory support

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación Científica Pulmón y Ventilación Mecánica

OTHER

Sponsor Role collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesus Villar

Clinical Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesús Villar, MD

Role: STUDY_CHAIR

Clinical Scientist

Robert M Kacmarek, PhD

Role: STUDY_CHAIR

Clinical Scientist

Locations

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Nevill Hall Hospital

Abergavenny, , United Kingdom

Site Status

Ysbyty Gwynedd

Bangor, , United Kingdom

Site Status

Cardiff University

Cardiff, , United Kingdom

Site Status

University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Glangwili General Hospital

Carmarthen, , United Kingdom

Site Status

Withybush General Hospital

Haverfordwest, , United Kingdom

Site Status

Royal Glamorgan Hospital

Llantrisant, , United Kingdom

Site Status

Prince Charles Hospital

Merthyr Tydfil, , United Kingdom

Site Status

Royal Gwent Hospital

Newport, , United Kingdom

Site Status

Ysbyty Glan Clwyd

Rhyl, , United Kingdom

Site Status

Morriston Hospital

Swansea, , United Kingdom

Site Status

Wrexham Maelor Hospital

Wrexham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ACPVM170916

Identifier Type: -

Identifier Source: org_study_id

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