Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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