NCT04541446

Brief Summary

Human participants will include medical residents. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
773

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

August 24, 2020

Last Update Submit

October 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Residents to receive Dynamic Haptic Robotic Training

EXPERIMENTAL
Other: Dynamic Haptic Robotic Trainer (DHRT)

Residents to receive Advanced Dynamic Haptic Robotic Training

EXPERIMENTAL
Other: Advanced Dynamic Haptic Robotic Trainer (DHRT+)

Interventions

Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization.

Residents to receive Dynamic Haptic Robotic Training

Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization.

Residents to receive Advanced Dynamic Haptic Robotic Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • new resident undergoing central venous catheterization training

You may not qualify if:

  • not a new resident undergoing central venous catheterization training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Scarlett R Miller, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR
  • Jason Z. Moore, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Engineering

Study Record Dates

First Submitted

August 24, 2020

First Posted

September 9, 2020

Study Start

August 19, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

October 30, 2025

Record last verified: 2025-10

Locations