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

NCT05410106 | Unknown

• 1 other identifier: 21/NOV/8290
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Aspiration; Infections; Ventilator Lung

Keywords

Ventilator Associated Pneumonia; endotracheal tube; Aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• To assess the feasibility of delivering the study intervention

  Duration of study treatment (typically 4-7 days)

• Number of participants with a failed pepsin test

  Duration of study treatment (typically 4-7 days)

• Number of participants with a positive pepsin tracheal aspirate sample using Peptest

  Duration of study treatment (typically 4-7 days)

• Volume of sub-glottic aspirates

  Duration of study treatment (typically 4-7 days)

• Rate of tracheobronchial colonization

  Duration of study treatment (typically 4-7 days)

Study Arms (2)

PneuX endotracheal tube

EXPERIMENTAL

Patients will be intubated using the PneuX endotracheal tube system

Device: PneuX Endotracheal Tube

Standard care

ACTIVE COMPARATOR

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

Device: Standard care (Taperguard, Covidien)

Interventions

PneuX Endotracheal Tube DEVICE

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.

Also known as: Venner PneuX System

PneuX endotracheal tube

Standard care (Taperguard, Covidien) DEVICE

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (no upper age)
• Patient required endotracheal intubation
• Expect to remain intubated for 24 hours post randomisation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Cardiff University: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Infections

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Wise

  Cardiff and Vale University Health Board

  STUDY CHAIR

• Matthew Wise

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith White

CONTACT

02921844771; judith.white3@wales.nhs.uk

Rhys Morris

CONTACT

0292144772; Rhys.Morris@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the interventional device it is not possible to blind the care providers or outcome assessors to the intervention group. The trial participants will be unconscious/sedated for the duration of the period that the PneuX device or standard ETT is in place and therefore will be unaware of their allocation. Samples sent to the laboratory for analysis will be anonymised using individual deidentified numbers for each participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Feasibility, 2-arm, parallel, randomised controlled trial

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 8, 2022
• Study Start: December 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)