Comparing a new endotracheal tube to standard care for patients on ventilators
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)
This study is testing a new type of breathing tube for patients on ventilators to see if it works better than the standard tube and if it's safe to use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiff and Vale University Health Board Government |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT05410106 on ClinicalTrials.gov |
What this trial studies
This feasibility trial evaluates the use of the PneuX Endotracheal Tube (ETT) compared to standard care in patients requiring mechanical ventilation due to critical illness. Conducted at the University Hospital of Wales, the study will randomize 50 patients into two groups to assess various feasibility measures, including recruitment, intervention delivery, and device-related adverse events. The trial aims to gather data on the acceptability and adherence to the intervention, as well as the effectiveness of the PneuX ETT in reducing microaspiration. This study is crucial for determining whether a larger randomized controlled trial is viable.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 and older who require endotracheal intubation and are expected to remain intubated for at least 24 hours.
Not a fit: Patients who have already aspirated, have a Glasgow Coma Scale score of 7 or less, or have certain medical conditions such as pregnancy or tracheostomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients on mechanical ventilation by reducing the incidence of ventilator-associated pneumonia.
How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in improving outcomes for patients on mechanical ventilation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old (no upper age) * Patient required endotracheal intubation * Expect to remain intubated for 24 hours post randomisation Exclusion Criteria: * The person intubating the patient assesses that the patient has already aspirated. * GCS 7 or less on presentation to hospital * Patient is pregnant * Patient has tracheostomy * Patient has gastrectomy * Patients who have been intubated prior to arrival at hospital * Patients who are already endotracheally intubated and require a tube change.
Where this trial is running
Cardiff
- University Hospital of Wales — Cardiff, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Matthew Wise — Cardiff and Vale University Health Board
- Study coordinator: Judith White
- Email: judith.white3@wales.nhs.uk
- Phone: 02921844771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.