Ischemia Clinical Trial
Official title:
Effect of Subcutaneous Nitroglycerin on the Prevention of Radial Artery Occlusion After Radial Artery Catheterization in Pediatric Patients - a Prospective Randomized Controlled Trial
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 and improving 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 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 36 Months |
Eligibility | Inclusion Criteria: - Patients undergoing General anesthesia - Patients in the Intensive care unit - Arterial cannulation for hemodynamic monitoring, or multiple blood sample Exclusion Criteria: - Unstable vital signs, significant arrhythmia or hypotension, Shock - High risk of peripheral ischemia - Skin disease, infection, hematoma, recent cannulation at the radial artery - History of anaphylaxis to nitroglycerin |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | First attempt success rate (%) | Success at the first skin puncture | During radial artery cannulation (up to 1 hour) | |
Secondary | Size of radial artery (mm) | Internal diameter of radial artery | Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Overall attempt (number) | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) | |
Secondary | Overall Procedure time (seconds) | From ultrasound guidance, to Arterial waveform | During radial artery cannulation (up to 1 hour) | |
Secondary | Overall success rate (%) | Success within 2 skin puncture and within 10 minutes | During radial artery cannulation (up to 1 hour) | |
Secondary | Incidence of posterior wall puncture (%) | Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization | During radial artery cannulation (up to 1 hour) | |
Secondary | Number of arteries cannulated | Number of arteries cannulated for peripheral arterial catheterization | During radial artery cannulation (up to 1 hour) | |
Secondary | Malfunction of radial artery catheter | Invasive blood pressure monitoring, Sampling (%) | After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour) | |
Secondary | 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) | |
Secondary | Use of vasoactive drugs | The vasoactive drugs used between cannulation and removal of the radial arterial catheter (yes/no) | After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour) | |
Secondary | Duration of radial arterial catherization | Duration of radial arterial catherization (hours, minutes) | After radial artery cannulation assessed during anesthesia (up to 480 hour) |
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