Does the use of a simple portable ultrasound machine increase the success rate for femoral venous access in children and decrease complications?

ISRCTN	ISRCTN58225270
DOI	https://doi.org/10.1186/ISRCTN58225270
Secondary identifying numbers	N0045126775

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 29/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Steven Cray
Scientific

Birmingham Children's Hospital
Department of Anaesthesia
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Phone	+44 (0)121 333 9623
Email	steven.cray@bch.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Does the use of a simple portable ultrasound machine increase the success rate for femoral venous access in children and decrease complications?
Study objectives	Does the use of a simple portable ultrasound machine increase the success rate for femoral venous access in children and decrease complications?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	19/04/2004
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Approximately 30 patients will be required in each group for an alpha of 0.05 and beta 0.8.
Key inclusion criteria	Children undergoing cardiac catheterisation under general anaesthesia who require femoral venous access for the procedure
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	19/04/2004
Date of final enrolment	31/03/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Birmingham Children's Hospital

Birmingham
B4 6NH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Birmingham Children's Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/04/2016: No publications found, verifying study status with principal investigator