None listed
Conditions
Brief summary
Children with respiratory illness including CF and non CF bronchiectasis are the largest cohort of children requiring PICCs at Queensland Children's Hospital (QCH). Traditionally PICCs require a general anaesthesia to establish procedural compliance. Midlines are also used internationally to administer intravenous antibiotics without necessitating general anaesthesia. We hypothesise that the need for GA will be reduced in this patient cohort whilst still providing the necessary treatment. This will benefit this patient population and the healthcare institution through reduced procedural risk and corresponding respiratory compromise, as well as reduced costs associated with theatre personnel. . The primary aims of this research is 1) to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity and 2) need for general anaesthetic.
Interventions
Intervention: 3fr, 4fr (outer lumen midline size); power injectable midline catheter. Catheter size chosen by the operator inserting the device.
A midline catheter begins its insertion in a peripheral vein in the upper arm. Midlines are shorter devices and the tip of the midline terminates at the axilla. Xray is not required to check catheter tip position.
All catheters will be inserted by and appropriately trained anaesthetic consultant, registrar, fellow or nurse practitioner in vascular a
Intervention: 3fr, 4fr (outer lumen midline size); power injectable midline catheter. Catheter size chosen by the operator inserting the device. A midline catheter begins its insertion in a peripheral vein in the upper arm. Midlines are shorter devices and the tip of the midline terminates at the axilla. Xray is not required to check catheter tip position. All catheters will be inserted by and appropriately trained anaesthetic consultant, registrar, fellow or nurse practitioner in vascular access. All care and maintenance will be performed by appropriately trained nurses in the clinical area. All catheters will remain in place for the period of treatment between 12-21 days. Where a device is complicated by failure and a replacement device is required the same device will be reinserted if the patient and substitute decision maker are agreeable.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
. Respiratory diagnosis of CF or any other respiratory diagnosis including, non-CF bronchiectasis • 0 (>37 weeks) – 18 years of age (17 years + 364 days) • Referred to the vascular assessment and management service (VAMS) for insertion of a vascular access device to facilitate antibiotic therapy for pulmonary optimisation. • Infusates deemed compatible with peripheral/midline administration based on assessment of venous infusion extravasation risk English speaking Able to provide consent
Exclusion criteria
Update • Non-english speaking parent • Unable to provide consent • Previous enrolment in current trial • Thrombosis at level of axillar or sub-clavian that precludes insertion of midline or PICC - Medical diagnosis of behavioural condition. e.g. autism, ADHD that would make it impossible for a child to co-operate to a level necessary to have the device inserted with anaesthesia.
Outcome results
None listed