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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Ventilator Associated Pneumonia Aspiration Infections Ventilator Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Feasibility, 2-arm, parallel, randomised controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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PneuX endotracheal tube

Patients will be intubated using the PneuX endotracheal tube system

Group Type EXPERIMENTAL

PneuX Endotracheal Tube

Intervention Type 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.

Standard care

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

Group Type ACTIVE_COMPARATOR

Standard care (Taperguard, Covidien)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Venner PneuX System

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No