Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales

NCT03358043 | Completed

• 1 other identifier: ACPVM170916
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 12

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.).

Conditions

Acute Respiratory Insufficiency

Keywords

respiratory failure; mechanical ventilation; prevalence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Death in the hospital

  Hospital stay (maximum 6 months)

Interventions

mechanical ventilation DEVICE

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.

Also known as: ventilatory support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead
• Asociación Científica Pulmón y Ventilación Mecánica: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator

Study Sites (12)

Nevill Hall Hospital

Abergavenny, United Kingdom

Location

Ysbyty Gwynedd

Bangor, United Kingdom

Location

Cardiff University

Cardiff, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Glangwili General Hospital

Carmarthen, United Kingdom

Location

Withybush General Hospital

Haverfordwest, United Kingdom

Location

Royal Glamorgan Hospital

Llantrisant, United Kingdom

Location

Prince Charles Hospital

Merthyr Tydfil, United Kingdom

Location

Royal Gwent Hospital

Newport, United Kingdom

Location

Ysbyty Glan Clwyd

Rhyl, United Kingdom

Location

Morriston Hospital

Swansea, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiration, Artificial; Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Jesús Villar, MD

  Clinical Scientist

  STUDY CHAIR

• Robert M Kacmarek, PhD

  Clinical Scientist

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: October 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

GB (12)