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Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

Primary Purpose

Arterial Line, Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nitroglycerin
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arterial Line focused on measuring Radial Artery, Vascular Catheters

Eligibility Criteria

undefined - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nitroglycerin

Control

Arm Description

Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.

Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.

Outcomes

Primary Outcome Measures

The incidence of radial arterial occlusion (RAO) (%)
RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.

Secondary Outcome Measures

First attempt success rate (%)
Success at the first skin puncture
Size of radial artery (mm)
Internal diameter of radial artery
depth of radial artery (mm)
depth of radial artery from the skin
flow velocity of the radial artery (cm/s)
flow velocity of the radial artery measured by Doppler ultrasound
Perfusion index
Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization
Overall attempt (number)
Number of attempt of radial artery cannulation
Overall Procedure time (seconds)
From ultrasound guidance, to Arterial waveform
Overall success rate (%)
Success within 2 skin puncture and within 10 minutes
Incidence of posterior wall puncture (%)
Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization
Number of arteries cannulated
Number of arteries cannulated for peripheral arterial catheterization
Malfunction of radial artery catheter
Invasive blood pressure monitoring, Sampling (%)
Complication rate
Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)
Use of vasoactive drugs
The vasoactive drugs used between cannulation and removal of the radial arterial catheter (yes/no)
Duration of radial arterial catherization
Duration of radial arterial catherization (hours, minutes)
Surface temperature of ipsilateral hand at the removal of radial arterial catheter
Surface temperature of ipsilateral hand at the removal of radial arterial catheter (℃)

Full Information

First Posted
June 29, 2022
Last Updated
September 25, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05443061
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 and improving 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Line, Ischemia
Keywords
Radial Artery, Vascular Catheters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitroglycerin
Arm Type
Experimental
Arm Description
Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Primary Outcome Measure Information:
Title
The incidence of radial arterial occlusion (RAO) (%)
Description
RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.
Time Frame
After removal of the radial artery catheter (up to 24 hour)
Secondary Outcome Measure Information:
Title
First attempt success rate (%)
Description
Success at the first skin puncture
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Size of radial artery (mm)
Description
Internal diameter of radial artery
Time Frame
Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Title
depth of radial artery (mm)
Description
depth of radial artery from the skin
Time Frame
Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Title
flow velocity of the radial artery (cm/s)
Description
flow velocity of the radial artery measured by Doppler ultrasound
Time Frame
Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Title
Perfusion index
Description
Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization
Time Frame
Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)
Title
Overall attempt (number)
Description
Number of attempt of radial artery cannulation
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Overall Procedure time (seconds)
Description
From ultrasound guidance, to Arterial waveform
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Overall success rate (%)
Description
Success within 2 skin puncture and within 10 minutes
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Incidence of posterior wall puncture (%)
Description
Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Number of arteries cannulated
Description
Number of arteries cannulated for peripheral arterial catheterization
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Malfunction of radial artery catheter
Description
Invasive blood pressure monitoring, Sampling (%)
Time Frame
After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)
Title
Complication rate
Description
Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)
Time Frame
After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour)
Title
Use of vasoactive drugs
Description
The vasoactive drugs used between cannulation and removal of the radial arterial catheter (yes/no)
Time Frame
After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)
Title
Duration of radial arterial catherization
Description
Duration of radial arterial catherization (hours, minutes)
Time Frame
After radial artery cannulation assessed during anesthesia (up to 480 hour)
Title
Surface temperature of ipsilateral hand at the removal of radial arterial catheter
Description
Surface temperature of ipsilateral hand at the removal of radial arterial catheter (℃)
Time Frame
After removal of the radial artery catheter (up to 24 hour)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Eun Jang, MD, PhD
Phone
82-2-2072-3650
Email
na0ag2@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Eun Jang, MD, PhD
Organizational Affiliation
Clinical assistant professor, Department of anesthesiology and pain medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Eun Jang, MD, PhD
Phone
82-2-2072-3650
Email
na0ag2@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32282432
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.
Results Reference
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PubMed Identifier
34352073
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.
Results Reference
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PubMed Identifier
31356376
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.
Results Reference
background
PubMed Identifier
28682811
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.
Results Reference
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Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

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