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Completed

NCT Number: NCT05443061

Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

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.

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Key information

Conditions

Arterial Line Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin

Drug

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

normal saline

Drug

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

Primary outcomes

  1. The incidence of radial arterial occlusion (RAO) (%)

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

    RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.

Secondary outcomes

  1. First attempt success rate (%)

    Time frame: During radial artery cannulation (up to 1 hour)

    Success at the first skin puncture

  2. Size of radial artery (mm)

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

    Internal diameter of radial artery

  3. depth of radial artery (mm)

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

    depth of radial artery from the skin

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

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

    flow velocity of the radial artery measured by Doppler ultrasound

  5. Perfusion index

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

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

  6. Overall attempt (number)

    Time frame: During radial artery cannulation (up to 1 hour)

    Number of attempt of radial artery cannulation

  7. Overall Procedure time (seconds)

    Time frame: During radial artery cannulation (up to 1 hour)

    From ultrasound guidance, to Arterial waveform

  8. Overall success rate (%)

    Time frame: During radial artery cannulation (up to 1 hour)

    Success within 2 skin puncture and within 10 minutes

  9. Incidence of posterior wall puncture (%)

    Time frame: During radial artery cannulation (up to 1 hour)

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

  10. Number of arteries cannulated

    Time frame: During radial artery cannulation (up to 1 hour)

    Number of arteries cannulated for peripheral arterial catheterization

  11. Malfunction of radial artery catheter

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

    Invasive blood pressure monitoring, Sampling (%)

  12. Complication rate

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

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

  13. Duration of radial arterial catherization

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

    Duration of radial arterial catherization (hours, minutes)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Subcutaneous Nitroglycerin on the Prevention of Radial Artery Occlusion After Radial Artery Catheterization in Pediatric Patients - a Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2022
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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