Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT) (VAP-X)

Cardiff and Vale University Health Board

Status: Enrolling

Conditions: Ventilator Associated Pneumonia; Ventilator Lung; Aspiration; Infections

Treatments: Device: Standard care (Taperguard, Covidien); Device: PneuX Endotracheal Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT05410106

21/NOV/8290

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

PneuX endotracheal tube

Experimental group

Description:

Patients will be intubated using the PneuX endotracheal tube system

Treatment:

Device: PneuX Endotracheal Tube

Standard care

Active Comparator group

Description:

Patients will be intubated using standard endotracheal tube (Taperguard, Covidien).

Treatment:

Device: Standard care (Taperguard, Covidien)