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Arterial LineNCT05443061

Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

A study testing Nitroglycerin and Normal saline in people with Arterial Line and Ischemia, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 36 months
Conditions the study is for
Arterial Line, Ischemia
What is being tested?
Nitroglycerin and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Korea
Study dates
8 Sep 2022to 24 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients undergoing General anesthesia
  • Patients in the Intensive care unit
  • Arterial cannulation for hemodynamic monitoring, or multiple blood sample

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Nitroglycerin, Normal saline
Keywords
Radial Artery, Vascular Catheters
Medical subject headings
Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitroglycerinDrug

    Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

  • Normal salineDrug

    Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.

Study groups in NCT05443061
Study groupRoleWhat they receive
NitroglycerinExperimentalNitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
Receives: Drug: Nitroglycerin
ControlActive comparatorNormal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After removal of the radial artery catheter (up to 24 hour)

Secondary outcomes (13)

  1. First attempt success rate (%)

    Success at the first skin puncture

    Measured: During radial artery cannulation (up to 1 hour)

  2. Size of radial artery (mm)

    Internal diameter of radial artery

    Measured: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

  3. depth of radial artery (mm)

    depth of radial artery from the skin

    Measured: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

  4. flow velocity of the radial artery (cm/s)

    flow velocity of the radial artery measured by Doppler ultrasound

    Measured: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

  5. Perfusion index

    Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization

    Measured: Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)

  6. Overall attempt (number)

    Number of attempt of radial artery cannulation

    Measured: During radial artery cannulation (up to 1 hour)

  7. Overall Procedure time (seconds)

    From ultrasound guidance, to Arterial waveform

    Measured: During radial artery cannulation (up to 1 hour)

  8. Overall success rate (%)

    Success within 2 skin puncture and within 10 minutes

    Measured: During radial artery cannulation (up to 1 hour)

  9. Incidence of posterior wall puncture (%)

    Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization

    Measured: During radial artery cannulation (up to 1 hour)

  10. Number of arteries cannulated

    Number of arteries cannulated for peripheral arterial catheterization

    Measured: During radial artery cannulation (up to 1 hour)

  11. Malfunction of radial artery catheter

    Invasive blood pressure monitoring, Sampling (%)

    Measured: After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)

  12. Complication rate

    Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)

    Measured: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour)

  13. Duration of radial arterial catherization

    Duration of radial arterial catherization (hours, minutes)

    Measured: After radial artery cannulation assessed during anesthesia (up to 480 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start8 Sep 2022
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443061
Sponsor's protocol ID
H-2206-070-1332
Status last verified
Apr 2025
First submitted
29 Jun 2022
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32282432

  • 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.

    PubMed 34352073

  • 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.

    PubMed 31356376

  • 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.

    PubMed 28682811

  • Park JB, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT, Jang YE. Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Pediatric Patients: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1283-1290. doi: 10.1001/jamapediatrics.2025.3652.

    PubMed 41051743

Questions about this trial

What is this clinical trial studying?

A study testing Nitroglycerin and Normal saline in people with Arterial Line and Ischemia, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of radial arterial occlusion (RAO) (%) (time frame: After removal of the radial artery catheter (up to 24 hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443061, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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