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Completed

NCT Number: NCT04329026

Smart-glasses During the US-guided Radial Arterial Catheterization in Pediatric Patients: a RCT

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia.

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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

  • Unstable vital sign, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at radial artery

Treatment and study plan

Smart glasses

Device

The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.

Control

Device

The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

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: During radial artery cannulation (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 needle puncture, to Arterial waveform

  5. Overall success rate

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

    Success within 2 skin puncture and within 10 minutes at the chosen radial artery

  6. Malfunction of radial artery catheter

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

    Malfunction of Invasive blood pressure monitoring, Sampling

  7. Complication rate

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

    Hematoma, Distal ischemia, Spasm accessed by ultrasound

  8. Operator's satisfaction

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

    Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2020
Registry last updated
Feb 18, 2021

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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