AR for Pediatric Central Venous Catheterization

Anesthesia Clinical Trial

Official title:

The Usefulness of Smart-glasses During Ultrasound-guided Central Venous Catheterization in Pediatric Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04378166
• Other study ID #: 2003-018-1106
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Sang-Hwan Ji, M.D., M.S.
• Phone: 82-2-2072-3661
• Email: taepoongshin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study.

Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group.

Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Patients who are planned to undergo surgery under general anesthesia

• Patients in need for central venous catheterization during anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Smart glass
Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall success rate	Overall success rate of central venous catheterization	From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.
Secondary	Elapsed time for catheterization	Overall elapsed time of central venous catheterization	From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.
Secondary	Complication	Incidence and characteristics of complication related to central venous catheterization	From end of catheterization to 24 hours after catheterization
Secondary	Satisfaction score	5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst)	From start of catheterization to end of catheterization. Not to exceed 20 minutes.