Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436117979
Study information
Scientific title
Acronym
Study hypothesis
To measure the accuracy of the Vasotrac® monitor compared with an arterial line in the morbidly obese patient. If there is agreement we may be able to use it instead.
Ethics approval
Not provided at time of registration
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Hypertension
Intervention
Randomised controlled trial. Random allocation to:
1. Blood pressure monitor
2. Arterial cannula
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The correlation of readings between the readings from the Vasotrac and an arterial line.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2002
Overall trial end date
01/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any patient presenting for surgery with a body mass index (BMI) >35 and requiring arterial cannula.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/07/2002
Recruitment end date
01/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Leeds
LS1 3EX
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
Leeds Teaching 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
Basic results (scientific)
Publication list