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
Secondary identifying numbers	9831

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

Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Phone	+44 1902 307 999
Email	shameer.gopal@nhs.net

Study information

Study design	Randomised; Interventional; Design type: Prevention, Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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	Proportion of patients who develop VAP between the two groups; Timepoint(s): Within 48 hours of extubation
Secondary outcome measures	Not provided at the time of registration
Overall study start date	17/01/2011
Completion date	16/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 240; UK Sample Size: 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

England
United Kingdom

Study participating centre

Wolverhampton Road , Heath Town

Wolverhampton
WV10 0QP
United Kingdom

Sponsor information

Royal Wolverhampton Hospitals NHS Trust (UK)
Hospital/treatment centre

Royal Wolverhampton NHS Trust, New Cross Hospital
Wolverhampton
WV10 0QP
England
United Kingdom

"ROR"	https://ror.org/05pjd0m90

Funders

Funder type

Government

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/05/2017: No publications found in PubMed, verifying study status with principal investigator