None listed
Conditions
Brief summary
The Queensland Children’s Hospital and Perth Children’s Hospital have identified a need to determine if SASS is superior to SSD for PICC and tunnelled CVC securement for; a) patients requiring PICC that have compromised skin integrity and b) all patients requiring insertion of tunnelled CVC. The results of this study will inform paediatric healthcare practice, provide reliable estimates of the comparative effect of SASS, and inform the feasibility of conducting a larger, definitive trial. We have completed an inbuilt feasibility study (n=60) and are continuing on to a powered RCT.
Interventions
SecurAcath Registered Trademark is a subcutaneously anchored securement system (SASS) that has small, blunt, nitinol, flexible feet placed just beneath the skin which act to stabilize the peripherally inserted central catheter (PICC) or Central venous catheters (CVC) at the point of insertion or catheter exit.
The inserting clinician will place the SASS, this clinician will be an advanced practitioner with anaesthetic and vascular access skills (e.g. Nurse practitioner, anaesthetist). The interv
SecurAcath Registered Trademark is a subcutaneously anchored securement system (SASS) that has small, blunt, nitinol, flexible feet placed just beneath the skin which act to stabilize the peripherally inserted central catheter (PICC) or Central venous catheters (CVC) at the point of insertion or catheter exit. The inserting clinician will place the SASS, this clinician will be an advanced practitioner with anaesthetic and vascular access skills (e.g. Nurse practitioner, anaesthetist). The intervention will be delivered in clinical practice, face-to-face. The intervention will be delivered on catheter insertion, at a single time point and will remain in place for the duration of the catheter. The intervention will occur at the hospital site. If dislodgement occurs SASS will be removed with the device, if required a new device will be inserted based on treating clinician preference. Intervention fidelity will be monitored and promoted by the clinician research nurse using medical notes and through participation in the insertion procedure. It is anticipated the study will run for 52 weeks as detailed in the dates section
Sponsors
Queenland Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Neonate to 18 years of age 2. Patients requiring PICC insertion (equal to or greater than a 3 fr) and/or 3. Insertion of tunnelled non-cuffed CVC (equal to or greater than a 3 fr) 4. Informed consent to participate
Exclusion criteria
1. Non-English speakers without an interpreter 2. Children under care of department of communities or without a legal guardian 3. Patient receiving end-of-life care 4. Previous enrolment in this study 5. Children with an indeterminate length of treatment (likely less than 2 weeks) 6. Known allergy to any of the study products.
Outcome results
None listed