Contact information
Type
Scientific
Primary contact
Dr Steven Cray
ORCID ID
Contact details
Birmingham Children's Hospital
Department of Anaesthesia
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
+44 (0)121 333 9623
steven.cray@bch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045126775
Study information
Scientific title
Does the use of a simple portable ultrasound machine increase the success rate for femoral venous access in children and decrease complications?
Acronym
Study hypothesis
Does the use of a simple portable ultrasound machine increase the success rate for femoral venous access in children and decrease complications?
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac catheterisation
Intervention
Children undergoing cardiac catheterisation under general anaesthesia who require femoral venous access for that procedure will be randomised to either femoral venous access under ultrasound guidance or by the landmark method (palpation of the femoral artery). Children who are known to have thrombosed or abnormal venous anatomy will be excluded because these children will require specialised techniques of vascular access. A history of latex allergy will also be an exclusion criterion. The femoral venous puncture will be performed by a cardiologist trained in both techniques.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
The number of attempts to successful venous access, time taken and complications (arterial puncture, failure, haematoma) will be recorded. If after 15 minutes the vein has not been accessed, then this will be recorded as a failure of that technique and an alternative method of access used.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/04/2004
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Children undergoing cardiac catheterisation under general anaesthesia who require femoral venous access for the procedure
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Approximately 30 patients will be required in each group for an alpha of 0.05 and beta 0.8.
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
19/04/2004
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Birmingham Children's Hospital 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