Does the use of the Venner™ PneuX YP™ VAP prevention system reduce the risk of Ventilator Associated Pneumonia (VAP) following major heart surgery
| ISRCTN | ISRCTN45757289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45757289 |
| Protocol serial number | 9831 |
| Sponsor | Royal Wolverhampton Hospitals NHS Trust (UK) |
| Funder | Department of Health (UK) |
- Submission date
- 22/03/2011
- Registration date
- 22/03/2011
- Last edited
- 23/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shameer Gopal
Scientific
Scientific
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
| Phone | +44 1902 307 999 |
|---|---|
| shameer.gopal@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Prevention, Process of Care |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Does the use of the Venner™ PneuX YP™ VAP prevention system reduce the risk of Ventilator Associated Pneumonia (VAP) following major heart surgery |
| Study acronym | LoVAP |
| Study objectives | The aim of this trial to determine whether the VennerTM PneuX P.Y.TM VAP prevention system reduces the risk of developing ventilator-associated pneumonia compared to standard endotracheal tubes in high risk patients scheduled for elective major heart surgery. |
| Ethics approval(s) | 10/H1208/42 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular, Infection, Respiratory, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Infection (all Subtopics), Respiratory (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Infectious diseases and microbiology , Respiratory, Critical Care |
| Intervention | Endotracheal intubation, Standard endotracheal tube VS Venner Pneux YP VAP Preventon system tube; Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Proportion of patients who develop VAP between the two groups; Timepoint(s): Within 48 hours of extubation |
| Key secondary outcome measure(s) |
Not provided at the time of registration |
| Completion date | 16/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | 1. Male and female patients = 70 years scheduled for elective major heart surgery 2. Patients = 16 years with impaired left ventricular function scheduled for elective major heart surgery. Impaired left ventricular function is defined as left ventricular ejection fraction =49% Target Gender: Male & Female ; Lower Age Limit 16 years |
| Key exclusion criteria | 1. Patients under 16 years old 2. Patients who present as an emergency for major heart surgery 3. Patients in whom pneumonia is proven or suspected prior to surgery 4. Pregnant patients 5. Patients enrolled in another study 6. Patients who are unable to give written consent |
| Date of first enrolment | 17/01/2011 |
| Date of final enrolment | 16/08/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wolverhampton Road , Heath Town
Wolverhampton
WV10 0QP
United Kingdom
WV10 0QP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2017: No publications found in PubMed, verifying study status with principal investigator
