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: Prof Matt Wise, Critical Care Consultant, Cardiff & Vale UHB
Sponsor: Cardiff and Vale University Health Board (ref: 21/NOV/8290)
REC approval: 29th June 2022 (22/WA/0163)
Funding: Internal funding (manufacturer will supply device free of charge)
Trial registration: NCT05410106
Study protocol: HERE
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.
This is a single centre, open-label, feasibility randomised controlled trial. The study aims to assess the feasibility of conducting an RCT to compare the PneuX ETT with standard care in hospitalised patients requiring mechanical ventilation. The patient population for this study are those who are experiencing critical illness requiring intubation and ventilatory support. Patients will be randomised in equal proportions into one of 2 arms: to be intubated using a Venner PneuX Endotracheal Tube (ETT) or using the standard tube. For this feasibility study, a total of 50 patients will be randomised into two groups (25 in each). All patients will be recruited at a single site (University Hospital of Wales, part of Cardiff & Vale UHB). The study will investigate several feasibility measures including recruitment, delivery of the intervention (including device-related adverse events), acceptability and adherence to the intervention and sampling, use of Peptest to measure microaspiration events, rate of pepsin positive samples, rate of tracheobronchial colonisation (to be carried out by Cardiff University), volume of sub-glottic aspirate, rate of VAP, length of ICU and hospital stay, demonstrate the validity of study documentation and provide preliminary data for 50 patients. The data will inform the pilot and main phase of the study.