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)

Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years old (no upper age)

• Patient required endotracheal intubation

• Expect to remain intubated for 24 hours post randomisation

Locations
Other Locations
United Kingdom
University Hospital of Wales
RECRUITING
Cardiff
Contact Information
Primary
Judith White
judith.white3@wales.nhs.uk
02921844771
Backup
Rhys Morris
Rhys.Morris@wales.nhs.uk
0292144772
Time Frame
Start Date: 2022-12-05
Completion Date: 2024-12-31
Participants
Target number of participants: 50
Treatments
Experimental: PneuX endotracheal tube
Patients will be intubated using the PneuX endotracheal tube system
Active_comparator: Standard care
Patients will be intubated using standard endotracheal tube (Taperguard, Covidien).
Authors
Daniel Law
Related Therapeutic Areas
Sponsors
Leads: Cardiff and Vale University Health Board
Collaborators: Cardiff University

This content was sourced from clinicaltrials.gov

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