Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Arterial Line Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849183
• Other study ID #: H-1810-077-979
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: November 2019
• Source: Seoul National University Hospital
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Line

Intervention

Drug:
• Nitroglycerin
Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients
• Normal saline
Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate	Success at the first skin puncture	During radial artery cannulation (up to 1 hour)
Secondary	Size of radial artery	Internal diameter of radial artery	Before and after subcutaneous injection of drugs (up to 1 hour)
Secondary	depth of radial artery	depth of radial artery from the skin	Before and after subcutaneous injection of drugs (up to 1 hour)
Secondary	Overall attempt	Number of attempt of radial artery cannulation	During radial artery cannulation (up to 1 hour)
Secondary	Overall Procedure time	From ultrasound guidance, to Arterial waveform	During radial artery cannulation (up to 1 hour)
Secondary	Overall success rate	Success within 4 skin puncture (2 skin puncture at each radial artery)	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 (up to 24 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 48 hour)