Open vs ultrasound guided insertion of central venous lines in children

Safety and efficacy of Open vs Ultrasound guided tunnelled central venous access in children- A randomised controlled trial

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001079932

Acronym

CVLRCT

Enrollment

109

Registered

2020-10-20

Start date

2013-06-04

Completion date

2017-11-06

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is about comparing two techniques of inserting central venous lines and ports. These are special catheters inserted into a large vein in the neck for the purpose of administration of parenteral nutrition, chemotherapy or administration of other medications. Traditionally, this is performed by open surgery through a cut in the neck to expose the vein. The catheter is tunnelled from the chest up into the neck and inserted into the vein. This will be compared with ultrasound guided insertion. Using ultrasound the vein is identified and a needle inserted into the vein and then a wire threaded through. The tract will be dilated and the catheter passed through a sheath. This is an established technique of central vein access and we have used this at this Hospital for over 3 years now. Safety of this technique is now well established at our Hospital and internationally. There are no prospective studies comparing these two techniques. In children requiring long term treatment, infection and clotting of the vein may happen necessitating change of line and at times there is difficulty with access. We are comparing the two techniques to identify which of these is associated with lesser complications and loss of vein in the long term.

Interventions

Ultrasound guided percutaneous insertion of surgical central lines inserted for parenteral nutrition (TPN), chemotherapy, antibiotic therapy and replacement of haematological factors in children. The procedure will be performed by surgeons. Time taken for the procedure will be recorded. Adherence to protocol will monitored by audit of the operating notes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Days to 16 Years

Healthy volunteers

Inclusion criteria

All children >0 to 16 years referred for insertion of Hickman’s or Implantable vascular access device for total parenteral nutrition, chemotherapy or replacement therapy will be included in the study. The study will be performed at The Children’s Hospital at Westmead. Ultrasound guided access will be the study group compared to the control group of open cut down insertion

Exclusion criteria

1.Patients with loss of both internal jugular veins from prior catheter insertion will be excluded. 2. Children with vascular access into veins other than internal jugular vein.

Outcome results