None listed
Conditions
Brief summary
Children admitted to intensive care units require arterial cannulation for monitoring and blood sampling. In neonates, arterial access can be achieved through umbilical artery catheterization in the first 3-4 days, whereas in older infants and children it is via peripheral arteries. Even in neonates, umbilical arterial catheterization may not be feasible (e.g., abdominal surgical conditions). The radial, posterior tibial, and brachial arteries are commonly used for cannulation in children and neonates. The radial artery cannulation is also being increasingly used for percutaneous cardiac procedures. These arteries are of small calibre, which makes their localization and cannulation challenging and potentially unsuccessful. The radial artery is the most frequently used site for cannulation as it is superficial and has a relatively larger diameter compared to other peripheral arteries. Repeated attempts can lead to bleeding, spasm and dissection of the peripheral arteries. Ultrasound-guided insertion can increase cannulation success but requires high expertise. A recent paediatric audit found that even with ultrasound, the first attempt success rate was only 31%. Resource-limited settings may be limited by the expense of the ultrasound equipment and maintenance. Therefore, increasing the internal diameter and preventing vasospasm are important for successful peripheral arterial cannulation in neonates. Glyceryl trinitrate (GTN) has the potential to increase cannulation success in children by increasing the diameter of peripheral arteries and preventing vasospasm when used as a local application. We hypothesize that local application of GTN in the form of a transdermal patch will achieve adequate dilatation of the radial artery in neonates. We aim to conduct a randomised controlled trial to establish effectiveness and safety of local GTN in increasing the diameter of the radial artery in neonates.
Interventions
Glyceryl trinitrate (GTN) 5mg (MinitranTM 5mg/24hour patch) will be applied for 30min, 45min or 60min. Neonates will be allocated to either the local GTN group or control group as described below. Glyceryl trinitrate is a registered medication on the Australian Therapeutic Goods Registry.
GTN GROUP: in this group, GTN patch 5mg will be applied to the neonate at the site of the radial arterial cannulation for 30 minutes (Group A, n = 15) or 45 minutes (Group B, n = 15) or 60min (Group C, n=15). I
Glyceryl trinitrate (GTN) 5mg (MinitranTM 5mg/24hour patch) will be applied for 30min, 45min or 60min. Neonates will be allocated to either the local GTN group or control group as described below. Glyceryl trinitrate is a registered medication on the Australian Therapeutic Goods Registry. GTN GROUP: in this group, GTN patch 5mg will be applied to the neonate at the site of the radial arterial cannulation for 30 minutes (Group A, n = 15) or 45 minutes (Group B, n = 15) or 60min (Group C, n=15). Immediately after its application, the GTN patch will be covered with a CobanTM adhesive bandage to ensure blinding. Per infant, only one arterial site will be studied to ensure the samples are independent.
Sponsors
Perth Children's Hospital(Child And Adolescent Health Service)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
34 Weeks to 44 Weeks
Healthy volunteers
No
Inclusion criteria
1. Neonates >34 weeks of gestation admitted to Neonatal Intensive Care Unit (NICU) needing peripheral arterial line for sampling or invasive blood pressure monitoring. 2. Neonates >34 weeks of gestation admitted to NICU scheduled for elective surgery- general surgery needing peripheral arterial cannulation for hemodynamic monitoring or frequent blood sampling (Peri-operative).
Exclusion criteria
1. Neonates with previous attempts at radial arterial cannulation, hematomas at cannulation site, abnormal Allen’s test, hypercoagulable state, coagulopathy, and peripheral vascular disease. 2. Neonates with unstable vital signs including hypotension, shock or significant arrythmias. 3. Neonates undergoing cardiac surgery 4. Neonates with increased intracranial pressure, intracranial haemorrhage, and recent use of Sildenafil. 5. Neonates with visible deformity in the radial artery area.
Outcome results
None listed