Arterial Line
Conditions
Keywords
Radial Artery, Vascular Catheters
Brief summary
The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt success rate of radial artery cannulation. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.
Interventions
DRUGNitroglycerin
Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients
DRUGNormal saline
Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* General anesthesia * Arterial cannulation for hemodynamic monitoring, multiple blood sample
Exclusion criteria
* Hypersensitivity or contraindication to nitroglycerine * Unstable vital sign, significant arrhythmia or hypotension, Shock * High risk of peripheral ischemia * Skin disease, infection, hematoma, recent cannulation at radial artery. * Increased intracranial pressure, Intracranial hemorrhage * Glaucoma * Recent use of PDE5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First attempt success rate | During radial artery cannulation (up to 1 hour) | Success at the first skin puncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| depth of radial artery | Before and after subcutaneous injection of drugs (up to 1 hour) | depth of radial artery from the skin |
| Overall attempt | During radial artery cannulation (up to 1 hour) | Number of attempt of radial artery cannulation |
| Overall Procedure time | During radial artery cannulation (up to 1 hour) | From ultrasound guidance, to Arterial waveform |
| Size of radial artery | Before and after subcutaneous injection of drugs (up to 1 hour) | Internal diameter of radial artery |
| Malfunction of radial artery catheter | After radial artery cannulation assessed during anesthesia (up to 24 hour) | Invasive blood pressure monitoring, Sampling |
| Complication rate | After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour) | Hematoma, Distal ischemia, Spasm accessed by ultrasound |
| Overall success rate | During radial artery cannulation (up to 1 hour) | Success within 4 skin puncture (2 skin puncture at each radial artery) |
Countries
South Korea
Outcome results
None listed