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The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitroglycerin | Experimental | Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter. |
|
| Control | Active Comparator | Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin | Drug | Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of radial arterial occlusion (RAO) (%) | RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery. | After removal of the radial artery catheter (up to 24 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| First attempt success rate (%) | Success at the first skin puncture | During radial artery cannulation (up to 1 hour) |
| Size of radial artery (mm) | Internal diameter of radial artery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Eun Jang, MD, PhD | Clinical assistant professor, Department of anesthesiology and pain medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32282432 | Background | Jang YE, Ji SH, Kim EH, Lee JH, Kim HS, Mossad EB, Kim JT. Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Jul;133(1):53-63. doi: 10.1097/ALN.0000000000003308. | |
| 34352073 | Background | Jang YE, Cho SA, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT. Smart Glasses for Radial Arterial Catheterization in Pediatric Patients: A Randomized Clinical Trial. Anesthesiology. 2021 Oct 1;135(4):612-620. doi: 10.1097/ALN.0000000000003914. |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Normal saline | Drug | Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients. |
|
| Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) |
| depth of radial artery (mm) | depth of radial artery from the skin | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) |
| flow velocity of the radial artery (cm/s) | flow velocity of the radial artery measured by Doppler ultrasound | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) |
| Perfusion index | Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) |
| Overall attempt (number) | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) |
| Overall Procedure time (seconds) | From ultrasound guidance, to Arterial waveform | During radial artery cannulation (up to 1 hour) |
| Overall success rate (%) | Success within 2 skin puncture and within 10 minutes | During radial artery cannulation (up to 1 hour) |
| Incidence of posterior wall puncture (%) | Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization | During radial artery cannulation (up to 1 hour) |
| Number of arteries cannulated | Number of arteries cannulated for peripheral arterial catheterization | During radial artery cannulation (up to 1 hour) |
| Malfunction of radial artery catheter | Invasive blood pressure monitoring, Sampling (%) | After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour) |
| Complication rate | Hematoma, Distal ischemia, Spasm accessed by ultrasound (%) | After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour) |
| Duration of radial arterial catherization | Duration of radial arterial catherization (hours, minutes) | After radial artery cannulation assessed during anesthesia (up to 480 hour) |
| 31356376 | Background | Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064. |
| 28682811 | Background | Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774. |
| 41051743 | Derived | Park JB, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT, Jang YE. Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Pediatric Patients: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1283-1290. doi: 10.1001/jamapediatrics.2025.3652. |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |