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VAP-X study

 

Lay Summary

Critically ill patients needing ventilation to help them breathe have a tube placed in their windpipe. The breathing tube stops the body from coughing and swallowing, and so fluids from the mouth and stomach can travel to the lungs and cause pneumonia. A type of breathing tube called PneuX is designed to reduce the amount of fluid which can travel into the lungs by using a special inflatable cuff which forms a seal in the airway.

We need to carry out high quality research to test whether the PnueX tube reduces the amount of fluid which goes into the lungs compared to a standard breathing tube, and whether this reduces the chances of a patient getting pneumonia. Before we can do this, we need to find out whether a large study is feasible and to gather data which will help us design a future clinical trial.

We aim to recruit 50 critically ill patients from University Hospital of Wales who require a ventilation in an intensive care unit (ICU). Half of the patients will receive the PneuX tube and half will get the standard tube.

We will take samples from patients to find out whether fluid from the stomach, and bacteria, has entered the lungs, and whether patients get pneumonia. We will find out whether the study is feasible and if we can improve it.

Cedar's role

  • Protocol design, approvals and study initiation
  • Randomisation and data management
  • Monitoring and safety reporting
  • Analysis and reporting

Study Details

  • Full title of clinical trial: A single centre, open-label, feasibility randomised controlled trial to evaluate gastric microaspiration in critically ill patients intubated using the Venner PneuX system compared to standard of care using pepsin biomarker (VAP-X)
  • Study design: Single centre, open-label, feasibility randomised controlled trial
  • Chief Investigator: Dr Matt Wise, Critical Care Consultant
  • Sponsor: Cardiff and Vale University Health Board
  • Funding: Internal funding (manufacturer will supply device free of charge).