Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Arterial Line
• Intervention / Treatment: Drug: Nitroglycerin; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nitroglycerin; Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.	Drug: Nitroglycerin; Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients; Other Names: Subcutaneous Nitroglycerin
ACTIVE_COMPARATOR: Control; Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.	Drug: Normal saline; Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients; Other Names: Subcutaneous Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	Success at the first skin puncture	During radial artery cannulation (up to 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of radial artery	Internal diameter of radial artery	Before and after subcutaneous injection of drugs (up to 1 hour)
Overall attempt	Number of attempt of radial artery cannulation	During radial artery cannulation (up to 1 hour)
depth of radial artery	depth of radial artery from the skin	Before and after subcutaneous injection of drugs (up to 1 hour)
Overall Procedure time	From ultrasound guidance, to Arterial waveform	During radial artery cannulation (up to 1 hour)
Overall success rate	Success within 4 skin puncture (2 skin puncture at each radial artery)	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 (up to 24 hour)
Complication rate	Hematoma, Distal ischemia, Spasm accessed by ultrasound	After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Chong AY, Lo T, George S, Ratib K, Mamas M, Nolan J. The effect of pre-procedure sublingual nitroglycerin on radial artery diameter and Allen's test outcome - Relevance to transradial catheterization. Cardiovasc Revasc Med. 2018 Mar;19(2):163-167. doi: 10.1016/j.carrev.2017.07.016. Epub 2017 Jul 29.
• Chen Y, Ke Z, Xiao J, Lin M, Huang X, Yan C, Ye S, Tan X. Subcutaneous Injection of Nitroglycerin at the Radial Artery Puncture Site Reduces the Risk of Early Radial Artery Occlusion After Transradial Coronary Catheterization: A Randomized, Placebo-Controlled Clinical Trial. Circ Cardiovasc Interv. 2018 Jul;11(7):e006571. doi: 10.1161/CIRCINTERVENTIONS.118.006571.
• 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.
• Ezhumalai B, Satheesh S, Jayaraman B. Effects of subcutaneously infiltrated nitroglycerin on diameter, palpability, ease-of-puncture and pre-cannulation spasm of radial artery during transradial coronary angiography. Indian Heart J. 2014 Nov-Dec;66(6):593-7. doi: 10.1016/j.ihj.2014.05.023. Epub 2014 Jun 7.
• Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.
• Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ACTUAL): July 22, 2019
• Study Completion (ACTUAL): July 22, 2019

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Radial Artery; Vascular Catheters
• Additional Relevant MeSH Terms: Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: H-1810-077-979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No