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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Ventilator Associated Pneumonia; Ventilator Lung; Aspiration
• Intervention / Treatment: Device: PneuX Endotracheal Tube; Device: Standard care (Taperguard, Covidien)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith White; Phone Number: 02921844771; Email: judith.white3@wales.nhs.uk
• Study Contact Backup: Name: Rhys Morris; Phone Number: 0292144772; Email: Rhys.Morris@wales.nhs.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Recruiting
    • University Hospital of Wales
    • Contact: Jade Cole; Phone Number: 029 21 843608; Email: Jade.Cole@wales.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PneuX endotracheal tube; Patients will be intubated using the PneuX endotracheal tube system	Device: PneuX Endotracheal Tube; 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.; Other Names: Venner PneuX System
Active Comparator: Standard care; Patients will be intubated using standard endotracheal tube (Taperguard, Covidien).	Device: Standard care (Taperguard, Covidien); 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: Cardiff University
• Investigators: Study Chair: Matthew Wise, Cardiff and Vale University Health Board; Principal Investigator: Matthew Wise, Cardiff and Vale University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Aspiration; endotracheal tube; Ventilator Associated Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 21/NOV/8290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No