Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

NCT03849183 | Completed

• 1 other identifier: H-1810-077-979
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Line

Keywords

Radial Artery; Vascular Catheters

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  Success at the first skin puncture

  During radial artery cannulation (up to 1 hour)

Secondary Outcomes (7)

• Size of radial artery

  Before and after subcutaneous injection of drugs (up to 1 hour)

• depth of radial artery

  Before and after subcutaneous injection of drugs (up to 1 hour)

• Overall attempt

  During radial artery cannulation (up to 1 hour)

• Overall Procedure time

  During radial artery cannulation (up to 1 hour)

• Overall success rate

  During radial artery cannulation (up to 1 hour)

Study Arms (2)

Nitroglycerin

EXPERIMENTAL

Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.

Drug: Nitroglycerin

Control

ACTIVE COMPARATOR

Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.

Drug: Normal saline

Interventions

Nitroglycerin DRUG

Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Also known as: Subcutaneous Nitroglycerin

Nitroglycerin

Normal saline DRUG

Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Also known as: Subcutaneous Normal saline

Control

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• General anesthesia
• Arterial cannulation for hemodynamic monitoring, multiple blood sample

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (6)

• 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.

  PMID: 28923695 BACKGROUND

• 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.

  PMID: 30002088 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.

  PMID: 28682811 BACKGROUND

• 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.

  PMID: 25634390 BACKGROUND

• 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.

  PMID: 23582415 BACKGROUND

• 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.

  PMID: 22699036 BACKGROUND

MeSH Terms

Interventions

Nitroglycerin; Saline Solution

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: March 20, 2019
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

KR (1)