Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Ventilator Associated Pneumonia, Aspiration, Infections, Ventilator Lung

Intervention / Treatment
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* Device: PneuX Endotracheal Tube
* Device: Standard care (Taperguard, Covidien)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Feasibility, 2-arm, parallel, randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PneuX endotracheal tube<br>Patients will be intubated using the PneuX endotracheal tube system | Device: PneuX Endotracheal Tube<br>* The PneuX Endotracheal Tube is a CE marked device produced by Venner. The purpose of this product is to provide invasive ventilation for patients in the ICU. The defining features of the intervention treatment are the multi-modal approach to prevent microaspiration during long term ventilation.<br>* Other names: Venner PneuX System;|
| Active Comparator: Standard care<br>Patients will be intubated using standard endotracheal tube (Taperguard, Covidien). | Device: Standard care (Taperguard, Covidien)<br>* Standard care is to intubate patient using the Taperguard endotracheal tube (ETT). The Taperguard ETT is designed with a tracheal shaped cuff made of PVC. This has a single lumen subglottic port.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment | The recruitment rate will be assessed using the screening and recruitment log which will record the number of patients recruited each month and reasons for non-recruitment will be described | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of delivering the study intervention | Any issues experienced when using the study device at any point during the study will be recorded in the CRF, including device-related complications. | Duration of study treatment (typically 4-7 days) | 
| Number of participants with a failed pepsin test | Any issues such as failed sampling or failed testing will be recorded in case report form | Duration of study treatment (typically 4-7 days) | 
| Number of participants with a positive pepsin tracheal aspirate sample using Peptest | The proportion of tracheal aspirate samples which are positive for the presence of pepsin using the Peptest test | Duration of study treatment (typically 4-7 days) | 
| Volume of sub-glottic aspirates | The volume of the sub-glottic aspirates will be measured every 24 hours | Duration of study treatment (typically 4-7 days) | 
| Rate of tracheobronchial colonization | Tracheobronchial colonization (no. colony forming units/ml) present in sputum samples will be measured by culture on days 3 and 7 | Duration of study treatment (typically 4-7 days) | 
| Proportion of patients who require antibiotics | The following will be assessed: antibiotic prescribed, indication for use, number of days administered | 28 days | 
| Rate of Ventilator Associated Pneumonia (VAP) | Number of patients with VAP diagnosis. Clinical Pulmonary Infection Score (CPIS) used to predict VAP. CPIS >6 will be used to define confirmation of VAP. Measured daily after 48 hours of intubation | 28 days | 
| Time spent on the ventilator | Days spent with mechanical ventilation in ICU (from time/date of intubation to time/date of extubation or 28 days) | Duration of study treatment (typically 4-7 days) | 
| Number of days spent in ICU and hospital | Length of stay in ICU and length of stay in hospital measured in days from ventilation | 28 days | 
| Rate of in-hospital mortality | Number of patients who die in hospital up to 28 days after entry into ICU | 28 days | 
| Rate of compliance with measuring and documenting cuff pressure | Documentation of cuff pressures in both arms of study. Cuff pressure in standard care will be measured every 12 hours. Assessment of intervention arm will have documentation that pressure has been maintained hourly either via the continual cuff pressure monitor or manually. | Duration of study treatment (typically 4-7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator Associated Pneumonia, endotracheal tube, Aspiration