Ventilator Associated PneumoniaVAP-XNCT05410106
Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)
A study testing PneuX Endotracheal Tube in people with Ventilator Associated Pneumonia and Aspiration, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Aspiration, Infections
- What is being tested?
- PneuX Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old (no upper age)
- Patient required endotracheal intubation
- Expect to remain intubated for 24 hours post randomisation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
Jade Cole, 029 21 843608, Jade.Cole@wales.nhs.uk
About this study
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)
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.
- Being tested
- PneuX Endotracheal Tube, Standard care (Taperguard, Covidien)
- Keywords
- Ventilator Associated Pneumonia, endotracheal tube, Aspiration
- Medical subject headings
- Pneumonia, Ventilator-Associated, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneuX Endotracheal TubeDevice
Also called Venner PneuX System
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.
| Study group | Role | What they receive |
|---|---|---|
| PneuX endotracheal tube | Experimental | Patients will be intubated using the PneuX endotracheal tube system Receives: Device: PneuX Endotracheal Tube |
| Standard care | Active comparator | Patients will be intubated using standard endotracheal tube (Taperguard, Covidien). Receives: Device: Standard care (Taperguard, Covidien) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 28 days
Rate of in-hospital mortality
Number of patients who die in hospital up to 28 days after entry into ICU
Measured: 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.
Measured: Duration of study treatment (typically 4-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start5 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility, 2-arm, parallel, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
- Investigators
- Matthew Wise, Study chair, Cardiff and Vale University Health BoardMatthew Wise, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410106
- Sponsor's protocol ID
- 21/NOV/8290
- Acronym
- VAP-X
- Status last verified
- Aug 2023
- First submitted
- 18 May 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05410106
- Acronym / sponsor ID
- VAP-X / 21/NOV/8290
- Keywords
- Ventilator Associated Pneumonia, endotracheal tube, Aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Cardiff University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Feasibility, 2-arm, parallel, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| PneuX endotracheal tube | Experimental | Device: PneuX Endotracheal TubePatients will be intubated using the PneuX endotracheal tube system |
| Standard care | Active comparator | Device: Standard care (Taperguard, Covidien)Patients will be intubated using standard endotracheal tube (Taperguard, Covidien). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old (no upper age)
- Patient required endotracheal intubation
- Expect to remain intubated for 24 hours post randomisation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneuX Endotracheal TubeAlso: Venner PneuX SystemThe 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. | Device | PneuX endotracheal tube |
| 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. | Device | Standard care |
Primary outcome
To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment
Time frame: 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
11 secondary outcomes
To assess the feasibility of delivering the study intervention
Time frame: Duration of study treatment (typically 4-7 days)
Number of participants with a failed pepsin test
Time frame: Duration of study treatment (typically 4-7 days)
Number of participants with a positive pepsin tracheal aspirate sample using Peptest
Time frame: Duration of study treatment (typically 4-7 days)
Volume of sub-glottic aspirates
Time frame: Duration of study treatment (typically 4-7 days)
Rate of tracheobronchial colonization
Time frame: Duration of study treatment (typically 4-7 days)
Proportion of patients who require antibiotics
Time frame: 28 days
Rate of Ventilator Associated Pneumonia (VAP)
Time frame: 28 days
Time spent on the ventilator
Time frame: Duration of study treatment (typically 4-7 days)
Number of days spent in ICU and hospital
Time frame: 28 days
Rate of in-hospital mortality
Time frame: 28 days
Rate of compliance with measuring and documenting cuff pressure
Time frame: Duration of study treatment (typically 4-7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Wise study chair
Cardiff and Vale University Health Board
Matthew Wise principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PneuX Endotracheal Tube in people with Ventilator Associated Pneumonia and Aspiration, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith White (02921844771, judith.white3@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.