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Completed

NCT Number: NCT05030649

Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Trainees

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 by less experienced trainees. 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 by less experienced trainees.

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Key information

Conditions

Arterial Line

Age range

Up to 7 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 signs, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at theradial 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: During radial artery cannulation (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. Ultrasound image time

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

    From ultrasound probe application, to get radial artery image on the ultrasound screen

  5. Arterial cannulation time

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

    From needle puncture, to Arterial waveform

  6. Overall Procedure time

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

    From ultrasound probe application, to Arterial waveform

  7. 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

  8. 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

  9. 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

  10. Operator's experience

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

    The prior experience of the operator's in ultrasound-guided vascular cannulation (5-10 cannulations, 10-30 cannulations, 30-50 cannulations, 50-100 cannulations)

  11. 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 by Less Experienced Trainees: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Mar 7, 2023

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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