Clinical trial NCT05410106: Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Associated Pneumonia
Aspiration
Infections
Ventilator Lung
Keywords: Ventilator Associated Pneumonia
endotracheal tube
Aspiration
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
First posted: 2022-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility, 2-arm, parallel, randomised controlled trial
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: To assess the feasibility of delivering the study intervention
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Number of participants with a failed pepsin test
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Number of participants with a positive pepsin tracheal aspirate sample using Peptest
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Volume of sub-glottic aspirates
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Rate of tracheobronchial colonization
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Proportion of patients who require antibiotics
timeFrame: 28 days
measure: Rate of Ventilator Associated Pneumonia (VAP)
timeFrame: 28 days
measure: Time spent on the ventilator
timeFrame: Duration of study treatment (typically 4-7 days)
measure: Number of days spent in ICU and hospital
timeFrame: 28 days
measure: Rate of in-hospital mortality
timeFrame: 28 days
measure: Rate of compliance with measuring and documenting cuff pressure
timeFrame: Duration of study treatment (typically 4-7 days)
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Matthew Wise
role: STUDY_CHAIR
affiliation: Cardiff and Vale University Health Board
name: Matthew Wise
role: PRINCIPAL_INVESTIGATOR
References: