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

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ClinicalTrials.gov Identifier: NCT05030649
Recruitment Status : Completed
First Posted : September 1, 2021
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arterial Line Device: Smart glasses Device: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Less Experienced Trainees: a Randomized Controlled Trial
Actual Study Start Date : September 17, 2021
Actual Primary Completion Date : February 7, 2023
Actual Study Completion Date : February 7, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Smart Glasses
The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
 Device: Smart glasses
The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Active Comparator: Control
The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
 Device: Control
The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.


Outcome Measures
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Primary Outcome Measures :
  1. First attempt success rate [ Time Frame: During radial artery cannulation (up to 1 hour) ]
    Success at the first skin puncture


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030649


Locations
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Korea, Republic of
Jin-Tae Kim
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital
More Information
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Publications:

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05030649    
Other Study ID Numbers: Smart Glass A-line Less Exp
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
Radial Artery
Vascular Catheters
Smart Glassess
Less experienced