Condition category
Respiratory
Date applied
22/03/2011
Date assigned
22/03/2011
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shameer Gopal

ORCID ID

Contact details

Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
shameer.gopal@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9831

Study information

Scientific title

Acronym

LoVAP

Study hypothesis

Ventilator-associated pneumonia (VAP) is defined as pneumonia in patients who had a device to assist or control respiration continuously through an endotracheal or tracheostomy tube within a 48-hour period before the onset of the infection. Patients scheduled for major heart surgery are also at risk of developing VAP. The risk of VAP in this group of patients is 3.2 to 8.3%. However, subgroups of these patients are at a particularly high risk for developing VAP. Elderly patients over the age of 70 years, those with impaired ventricular function and those patients who remain on mechanical ventilation for more than 48 hours are at highest risk of developing VAP (13.9% incidence). VAP accounts for significant morbidity including increased length of hospital stay. The attributable mortality related to VAP may be as high as 20 to 60%. VAP is also responsible for a significant increase in cost. It is estimated that each episode of VAP may cost as much as £12,000.

It is 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

10/H1208/42

Study design

Randomised; Interventional; Design type: Prevention, Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

17/01/2011

Overall trial end date

16/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 240

Participant 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

Recruitment start date

17/01/2011

Recruitment end date

16/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolverhampton Road , Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Sponsor information

Organisation

Royal Wolverhampton Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes