Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0046145586
Study information
Scientific title
Acronym
Study hypothesis
To compare the use of Proseal LMA (PLMA) and andotracheal tube (ETT) for airway management during percutaneous tracheostomy in the Intensive Care Unit.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Tracheostomy
Intervention
Not provided at time of registration
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/10/2003
Overall trial end date
03/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Intensive care unit patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
52
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/10/2003
Recruitment end date
03/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Heartlands and Solihull NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department Research Fund
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