ACTRN12623000561684
Recruiting
未知
Assessing the impact of an intravenous biosensor on the prevention of infusate injuries throughout a child’s hospitalisation: A Type 1 Hybrid Randomised Controlled Trial
niversity of Queensland0 sites532 target enrollmentMay 25, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Extravasation injuries (caused by peripheral intravenous catheters of infants)
- Sponsor
- niversity of Queensland
- Enrollment
- 532
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Neonates (greater than or equal to 1250 grams \+ physically able to fit the IV sensor on the limb)
- •2\) Infants younger than one year
- •3\) Have an existing or new peripheral IVs (including long and traditional peripheral IV) inserted in the distal half of a limb (i.e. proximal to antecubital for upper limb).
- •4\) Peripheral IV anticipated to be in situ for \>24 hours,
- •5\) Planned administration via the study peripheral IV of either:
- •\-continuous fluids (for 4 hours or more) including blood products.
- •\-antimicrobials, or
- •\-intermediate to high risk infusates .
Exclusion Criteria
- •1\) Planned administration of lipid\-based infusate via study peripheral IV (e.g., propofol).
- •2\) Other types of vascular access devices, including midline catheters, peripheral arterial catheters and central venous catheters
- •3\) Pre\-existing skin condition effecting study peripheral IV site, e,g., i) atopic dermatitis or extensive erythema toxicum, ii) infectious diseases such as Staphylococcal scalded skin syndrome; iii) burn (e.g., heat, decontamination); iv) inherited conditions such as epidermolysis bullosa, ichthyosis and aplasia cutis congenita
- •4\) Previously enrolled in this study and randomized to one of the treatment conditions
- •5\) Currently receiving end of life and/or redirection of care.
Outcomes
Primary Outcomes
Not specified
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