Decision support system to evaluate VENTilation in ARDS

The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care. The protocol has been amended to include COVID-19 patients.

Status: Open and recruiting at RBHT

Type: Interventional

Funder: not available

Sponsor: Imperial College of Science, Technology and Medicine

CI: Dr Brijesh Patel

IRAS-Number: 266521

CPMS-ID: 43529

Approval Date: 13 April 2020

Description:

To study a novel intervention (device) or randomised clinical trial to compare interventions in clinical practice (managemeet of care & active monitoring)

Inclusion:

  • Invasive mechanical ventilation.
  • Within 1 week of a known clinical insult or new or worsening respiratory symptoms
  • Within 7 days of an acute and potentially reversible episode of acute respiratory failure (as determined by the treating physician).
  • Chest radiograph with bilateral infiltrates consistent with evidence of pulmonary oedema but not fully explained by cardiac failure.
  • Hypoxaemia as defined by PaO2/FiO2 of < = 300mmHg (or < = 40kPa) (pre-ECMO PaO2/FiO2 will be used should patient be placed on extracorporeal support).

For Healthy Volunteers criteria:

  • 18 years or older
  • Able to consent
  • Have mental capacity  

Exclusion:

  • Age < 18 years old.
  • The absence of an arterial catheter for blood sampling at study start.
  • Consent declined.
  • Over 7 days of mechanical ventilation.
  • Treatment withdrawal imminent within 24 hours.
  • DNAR (Do Not Attempt Resuscitation) order in place
  • Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
  • Veno-ArterialVA ECMO ECMO

For Healthy Volunteers criteria:

  • Blood borne viruses: HIV, Hep B, Hep C
  • Blood taken in the last 7 days
  • Under doctor for investigation
  • Haematological disease
  • Currently suffers from infection
  • Needle phobia
  • Problems with veins / vessels
  • Refusal