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

Cardiff and Vale University Health Board50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Ventilator Associated Pneumonia

Interventions

PneuX Endotracheal TubeDEVICE

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 (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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 28 days

Rate of in-hospital mortality

Number of patients who die in hospital up to 28 days after entry into ICU

Time frame: 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.

Time frame: Duration of study treatment (typically 4-7 days)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts