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NCT Number: NCT03849183

Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

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.

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Key information

Conditions

Arterial Line

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Nitroglycerin

Drug

Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Other names: Subcutaneous Nitroglycerin

normal saline

Drug

Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Other names: Subcutaneous Normal saline

Primary outcomes

  1. First attempt success rate

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

    Success at the first skin puncture

Secondary outcomes

  1. Size of radial artery

    Time frame: Before and after subcutaneous injection of drugs (up to 1 hour)

    Internal diameter of radial artery

  2. depth of radial artery

    Time frame: Before and after subcutaneous injection of drugs (up to 1 hour)

    depth of radial artery from the skin

  3. Overall attempt

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

    Number of attempt of radial artery cannulation

  4. Overall Procedure time

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

    From ultrasound guidance, to Arterial waveform

  5. Overall success rate

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

    Success within 4 skin puncture (2 skin puncture at each radial artery)

  6. Malfunction of radial artery catheter

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

    Invasive blood pressure monitoring, Sampling

  7. Complication rate

    Time frame: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)

    Hematoma, Distal ischemia, Spasm accessed by ultrasound

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2019
Registry last updated
Nov 6, 2019

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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