Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443061
• Other study ID #: H-2206-070-1332
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Young-Eun Jang, MD, PhD
• Phone: 82-2-2072-3650
• Email: na0ag2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arterial Line
• Ischemia

Intervention

Drug:
• Nitroglycerin
Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
• Normal saline
Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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

Outcome

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)