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

Central Line Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541446
• Other study ID #: STUDY00012206
• Secondary ID: R01HL127316
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Scarlett R Miller, Ph.D.
• Phone: 814-863-4143
• Email: scarlettmiller[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 625
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing central venous catheterization

Exclusion criteria:

• patient that is not undergoing central venous catheterization

Related Conditions & MeSH terms

• Central Line Complication
• Central Line Infection

Intervention

Other:
• Dynamic Haptic Robotic Trainer (DHRT)
Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization.
• Advanced Dynamic Haptic Robotic Trainer (DHRT+)
Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization.

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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