Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for CVC Insertion Training for Surgical Residents

Human participants will include medical residents and patients. Each year the entering 1st year medical residents at Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform these procedures using the DHRT or the DHRT+ devices. The resident's performance will be measured and evaluated by these devices during the training. The technique of the training does not differ from what is currently taught at either of these institutions. In addition the residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment the residents will perform CVC interventions on under supervision. During this supervision the attending will fill out a short survey about the residents performance. After the procedure the investigators will examine patient files to determine any changes in central line related complications and infection rates due to new clinical educational practices.

Study Overview

• Status: Recruiting
• Conditions: Central Line Complication; Central Line Infection
• Intervention / Treatment: Other: Dynamic Haptic Robotic Trainer (DHRT); Other: Advanced Dynamic Haptic Robotic Trainer (DHRT+)

• Study Type: Interventional
• Enrollment (Anticipated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scarlett R Miller, Ph.D.; Phone Number: 814-863-4143; Email: scarlettmiller@psu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Contact: Philip Ng, MD; Phone Number: 310-877-3385; Email: Philip.Ng@cshs.org
      • Contact: Michael Yang, MD; Phone Number: 6787568699; Email: Michael.Yang2@cshs.org
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Hershey Medical Center
      • Contact: Elizabeth Sinz, MD; Phone Number: 717-531-1706; Email: ehs10@psu.edu
      • Contact: David Han, MD; Phone Number: +1 717 531 8866; Email: dch15@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patient undergoing central venous catheterization

Exclusion criteria:

• patient that is not undergoing central venous catheterization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Residents to receive Dynamic Haptic Robotic Training	Other: Dynamic Haptic Robotic Trainer (DHRT); Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization.
Experimental: Residents to receive Advanced Dynamic Haptic Robotic Training	Other: Advanced Dynamic Haptic Robotic Trainer (DHRT+); Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central Line Related Complications due to new Resident Central Line Training Procedures	Through patient files complication rates will be measured through study completion, an average of one year after having procedure performed.	baseline (pre-intervention), post-intervention
Change in Central Line Related Infections due to new Resident Central Line Training Procedures	Through patient files post procedural infection rate is measured through study completion, an average of one year after having procedure performed.	baseline (pre-intervention), post-intervention

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Scarlett R Miller, Ph.D., Penn State University; Principal Investigator: Jason Z. Moore, Ph.D., Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00012206; R01HL127316 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No