AR for Pediatric Central Venous Catheterization

NCT04378166 | Unknown DMC

• 1 other identifier: 2003-018-1106
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 1st success rate

  Success rate of central venous catheterization in first trial

  From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.

Secondary Outcomes (4)

• Overall success rate

  From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.

• Elapsed time for catheterization

  From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.

• Complication

  From end of catheterization to 24 hours after catheterization

• Satisfaction score

  From start of catheterization to end of catheterization. Not to exceed 20 minutes.

Study Arms (2)

Smart glasses

EXPERIMENTAL

Application of smart glasses for ultrasound-guided central venous catheterization

Device: Smart glass

Control

NO INTERVENTION

Conventional ultrasound-guided central venous catheterization

Interventions

Smart glass DEVICE

Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization

Smart glasses

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who are planned to undergo surgery under general anesthesia
• Patients in need for central venous catheterization during anesthesia

You may not qualify if:

• Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein
• Patients with unstable vital sign prior to anesthetic induction
• Patients who are not eligible for catheterization at right internal jugular vein
• Refusal of legal guardian of patient

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (10)

• Alderson PJ, Burrows FA, Stemp LI, Holtby HM. Use of ultrasound to evaluate internal jugular vein anatomy and to facilitate central venous cannulation in paediatric patients. Br J Anaesth. 1993 Feb;70(2):145-8. doi: 10.1093/bja/70.2.145.

  PMID: 8435256 BACKGROUND

• Lau CS, Chamberlain RS. Ultrasound-guided central venous catheter placement increases success rates in pediatric patients: a meta-analysis. Pediatr Res. 2016 Aug;80(2):178-84. doi: 10.1038/pr.2016.74. Epub 2016 Apr 8.

  PMID: 27057741 BACKGROUND

• Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.

  PMID: 11012954 BACKGROUND

• de Souza TH, Brandao MB, Nadal JAH, Nogueira RJN. Ultrasound Guidance for Pediatric Central Venous Catheterization: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20181719. doi: 10.1542/peds.2018-1719.

  PMID: 30361397 BACKGROUND

• Hiranaka T, Nakanishi Y, Fujishiro T, Hida Y, Tsubosaka M, Shibata Y, Okimura K, Uemoto H. The Use of Smart Glasses for Surgical Video Streaming. Surg Innov. 2017 Apr;24(2):151-154. doi: 10.1177/1553350616685431. Epub 2017 Jan 9.

  PMID: 28068887 BACKGROUND

• Huang CY, Thomas JB, Alismail A, Cohen A, Almutairi W, Daher NS, Terry MH, Tan LD. The use of augmented reality glasses in central line simulation: "see one, simulate many, do one competently, and teach everyone". Adv Med Educ Pract. 2018 May 10;9:357-363. doi: 10.2147/AMEP.S160704. eCollection 2018.

  PMID: 29785148 BACKGROUND

• Rochlen LR, Levine R, Tait AR. First-Person Point-of-View-Augmented Reality for Central Line Insertion Training: A Usability and Feasibility Study. Simul Healthc. 2017 Feb;12(1):57-62. doi: 10.1097/SIH.0000000000000185.

  PMID: 27930431 BACKGROUND

• Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.

  PMID: 30442261 BACKGROUND

• Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.

  PMID: 23478546 BACKGROUND

• Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.

  PMID: 26248059 BACKGROUND

Study Officials

• Jin-Tae Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hwan Ji, M.D., M.S.

CONTACT

82-2-2072-3661; taepoongshin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: Compares central venous catheterization using smart-glasses and conventional method

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 12, 2020
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)