Aspiration, Infections, Ventilator Associated Pneumonia, Ventilator Lung
Conditions
Keywords
Ventilator Associated Pneumonia, endotracheal tube, Aspiration
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.
Interventions
DEVICEPneuX 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.
DEVICEStandard 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.
Sponsors
Cardiff University
Cardiff and Vale University Health Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Feasibility, 2-arm, parallel, randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment | Through study completion, an average of 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a failed pepsin test | Duration of study treatment (typically 4-7 days) | Any issues such as failed sampling or failed testing will be recorded in case report form |
| Number of participants with a positive pepsin tracheal aspirate sample using Peptest | Duration of study treatment (typically 4-7 days) | The proportion of tracheal aspirate samples which are positive for the presence of pepsin using the Peptest test |
| Volume of sub-glottic aspirates | Duration of study treatment (typically 4-7 days) | The volume of the sub-glottic aspirates will be measured every 24 hours |
| Rate of tracheobronchial colonization | Duration of study treatment (typically 4-7 days) | Tracheobronchial colonization (no. colony forming units/ml) present in sputum samples will be measured by culture on days 3 and 7 |
| Proportion of patients who require antibiotics | 28 days | The following will be assessed: antibiotic prescribed, indication for use, number of days administered |
| To assess the feasibility of delivering the study intervention | Duration of study treatment (typically 4-7 days) | 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 spent on the ventilator | Duration of study treatment (typically 4-7 days) | Days spent with mechanical ventilation in ICU (from time/date of intubation to time/date of extubation or 28 days) |
| Number of days spent in ICU and hospital | 28 days | Length of stay in ICU and length of stay in hospital measured in days from ventilation |
| Rate of in-hospital mortality | 28 days | Number of patients who die in hospital up to 28 days after entry into ICU |
| Rate of compliance with measuring and documenting cuff pressure | Duration of study treatment (typically 4-7 days) | 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. |
| Rate of Ventilator Associated Pneumonia (VAP) | 28 days | 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 |
Countries
United Kingdom
Contacts
Primary ContactJudith White
Backup ContactRhys Morris
Outcome results
None listed