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 |
| Protocol serial number | N0045126775 |
| Sponsor | Department of Health |
| Funder | Birmingham Children's Hospital NHS Trust (UK) |
- 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
Scientific
Birmingham Children's Hospital
Department of Anaesthesia
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
| Phone | +44 (0)121 333 9623 |
|---|---|
| steven.cray@bch.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 30 |
| 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
- United Kingdom
- England
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/04/2016: No publications found, verifying study status with principal investigator
