Clinical trial NCT05443061: Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Line
Ischemia
Keywords: Radial Artery
Vascular Catheters
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 200
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of radial arterial occlusion (RAO) (%)
timeFrame: After removal of the radial artery catheter (up to 24 hour)
Secondary outcomes:
measure: First attempt success rate (%)
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Size of radial artery (mm)
timeFrame: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
measure: depth of radial artery (mm)
timeFrame: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
measure: flow velocity of the radial artery (cm/s)
timeFrame: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
measure: Perfusion index
timeFrame: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
measure: Overall attempt (number)
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall Procedure time (seconds)
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall success rate (%)
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Incidence of posterior wall puncture (%)
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Number of arteries cannulated
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Malfunction of radial artery catheter
timeFrame: After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)
measure: Complication rate
timeFrame: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour)
measure: Duration of radial arterial catherization
timeFrame: After radial artery cannulation assessed during anesthesia (up to 480 hour)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Clinical assistant professor, Department of anesthesiology and pain medicine
name: Young-Eun Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.