Ventilator Aspiration with PneuX
Research type
Research Study
Full title
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).
IRAS ID
311959
Contact name
Matthew Wise
Contact email
Sponsor organisation
Cardiff & Vale University Health Board
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research 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.
Summary of Results
Patients in the ICU often need a ventilator to help them breathe. Being on a ventilator means patients have a tube placed in their windpipe and this can increase the risk of developing a lung infection called pneumonia. Pneumonia is often caused by fluids from the mouth and stomach travelling past the breathing tube and into the lungs. 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 wanted to find out whether using the PneuX tube can reduce the amount of fluid which travels into the lungs, and also whether it can reduce the risk of patients developing pneumonia.
We set up a small research study to find out whether it is feasible to carry out a large clinical trial to compare the PneuX breathing tube with the usual tube which is currently used in hospitals. We aimed to recruit 50 patients who were critically unwell in the intensive care unit (ICU) and to take samples of sputum from their lungs to measure whether stomach fluids were passing into the lungs.The study had to be stopped after only 24 participants were recruited. The research team decided that it was not feasible to complete the study. Several challenges were encountered including not being able to recruit enough patients into the study, difficulties in using the PneuX tube, and challenges taking the sputum samples from participants' lungs. Many of the lessons learned in the this study can help improve the design of future work in this area.
REC name
Wales REC 3
REC reference
22/WA/0163
Date of REC Opinion
16 Jun 2022
REC opinion
Favourable Opinion