Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0025121900
Study information
Scientific title
Use of tracheostomy tubes with removeable inner cannula to prevent ventilator-associated pneumonia (VAP)
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Infections and Infestations: Pneumonia
Intervention
Randomised controlled pilot study to investigate whether using a tracheostomy tube with a removeable inner cannula and cleaning this daily could reduce incidence of VAP due to re-infection by an organism to which the patient has been previously exposed and reduce development of resistant organisms.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/01/2003
Overall trial end date
31/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 patients over 18 years, 20 with study tracheostomy tube and 20 with standard tracheostomy tube. Data to be analysed at this point.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/01/2003
Recruitment end date
31/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Aintree Hospitals NHS Trust (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