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

Infections Clinical Trial

— VAP-X  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410106
• Other study ID #: 21/NOV/8290
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Cardiff and Vale University Health Board
• Contact: Judith White
• Phone: 02921844771
• Email: judith.white3[@]wales.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspiration
• Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia
• Ventilator Lung

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University Hospital of Wales	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Proportion of patients who require antibiotics	The following will be assessed: antibiotic prescribed, indication for use, number of days administered	28 days
Secondary	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
Secondary	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)
Secondary	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
Secondary	Rate of in-hospital mortality	Number of patients who die in hospital up to 28 days after entry into ICU	28 days
Secondary	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)