Clinical trial NCT03849183: Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation
Official title: The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Line
Keywords: Radial Artery
Vascular Catheters
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 116
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: First attempt success rate
timeFrame: During radial artery cannulation (up to 1 hour)
Secondary outcomes:
measure: Size of radial artery
timeFrame: Before and after subcutaneous injection of drugs (up to 1 hour)
measure: depth of radial artery
timeFrame: Before and after subcutaneous injection of drugs (up to 1 hour)
measure: Overall attempt
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall Procedure time
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall success rate
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Malfunction of radial artery catheter
timeFrame: After radial artery cannulation assessed during anesthesia (up to 24 hour)
measure: Complication rate
timeFrame: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.