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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04541446
Collaborator
(none)
625
2
2
46.4
312.5
6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic Haptic Robotic Trainer (DHRT)
  • Other: Advanced Dynamic Haptic Robotic Trainer (DHRT+)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
625 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for CVC Insertion Training for Surgical Residents
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Central Line Related Complications due to new Resident Central Line Training Procedures [baseline (pre-intervention), post-intervention]

    Through patient files complication rates will be measured through study completion, an average of one year after having procedure performed.

  2. Change in Central Line Related Infections due to new Resident Central Line Training Procedures [baseline (pre-intervention), post-intervention]

    Through patient files post procedural infection rate is measured through study completion, an average of one year after having procedure performed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patient undergoing central venous catheterization
Exclusion criteria:
  • patient that is not undergoing central venous catheterization

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars Sinai Medical Center Los Angeles California United States 90048
2 Hershey Medical Center Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Scarlett R Miller, Ph.D., Penn State University
  • Principal Investigator: Jason Z. Moore, Ph.D., Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scarlett Miller, Associate Professor, Engineering, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT04541446
Other Study ID Numbers:
  • STUDY00012206
First Posted:
Sep 9, 2020
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 16, 2022