DHRT Training Devices for Central Venous Catheter Placement Skills

No longer recruiting at 1 trial location

Overseen By Scarlett R Miller, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Not undergoing central venous catheterization

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how medical residents learn to place central venous catheters, which are tubes inserted into large veins. The researchers seek to determine if advanced robotic training devices, such as the Dynamic Haptic Robotic Trainer (DHRT) or the Advanced Dynamic Haptic Robotic Trainer (DHRT+), enhance residents' performance and reduce complications like infections. Medical residents at selected hospitals will train with either the basic or advanced version of a robotic device. Patients undergoing central venous catheterization might participate in this trial as residents practice under supervision. As an unphased trial, this study focuses on enhancing medical training and offers patients the opportunity to contribute to improved healthcare practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these training devices are safe for medical residents?

Research has shown that the Dynamic Haptic Robotic Trainer (DHRT) and its advanced version, DHRT+, effectively teach medical residents how to insert central venous catheters. These devices allow residents to practice crucial steps safely before working on real patients. By simulating the procedure, they help residents build confidence and skills in a controlled environment.

As DHRT and DHRT+ are training tools not used directly on patients, no negative effects have been reported. They provide a safe practice method, reducing the chance of complications during actual procedures. These devices aim to lower the risk of issues like infections and mechanical problems when residents perform the procedure on patients.

In summary, the safety of DHRT and DHRT+ stems from their role as educational tools. No direct risks to patients have been reported from their use in training medical professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DHRT Training Devices for Central Venous Catheter Placement Skills because they offer a cutting-edge approach to medical training. Unlike traditional methods that rely on static mannequins or observational learning, these devices use advanced haptic technology to provide a dynamic, hands-on experience. The Advanced Dynamic Haptic Robotic Trainer (DHRT+) and the Dynamic Haptic Robotic Trainer (DHRT) give medical residents realistic feedback and a safe environment to develop their skills. This innovative training could lead to better outcomes and increased confidence in real clinical settings.

What evidence suggests that these training devices are effective for improving central venous catheter placement skills?

This trial will compare the effectiveness of the Dynamic Haptic Robotic Trainer (DHRT) and the Advanced Dynamic Haptic Robotic Trainer (DHRT+) in enhancing medical residents' ability to perform central venous catheterization. Research has shown that both devices significantly improve skills by providing a realistic and controlled practice environment, which reduces complications during the procedure. The DHRT+ proves particularly effective, boosting residents' confidence and skills more than the DHRT alone. One study confirmed that residents trained with these devices experienced fewer mechanical problems and infections when performing the procedure on real patients. This evidence suggests that using DHRT and DHRT+ in training can lead to safer and more successful central venous catheter placements. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Z. Moore, Ph.D.

Principal Investigator

Penn State University

Scarlett R Miller, Ph.D.

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for medical residents learning to insert central venous catheters (CVCs) and patients undergoing CVC procedures. Residents must be in their first year at Hershey Medical Center or Cedars-Sinai Medical Center, and patients must be scheduled for a CVC insertion.

Inclusion Criteria

I am getting a central venous catheter placed.

Exclusion Criteria

Patient that is not undergoing central venous catheterization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Medical residents are trained using the DHRT or DHRT+ devices and their performance is evaluated.

4-8 weeks

Multiple sessions (in-person)

Skills Assessment

Residents are required to pass a skills assessment currently required at their institution.

1-2 weeks

Supervised CVC Interventions

Residents perform CVC interventions under supervision, and attending physicians fill out performance surveys.

4-6 weeks

Follow-up

Investigators examine patient files to determine changes in central line related complications and infection rates.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Dynamic Haptic Robotic Trainer (DHRT+)
• Dynamic Haptic Robotic Trainer (DHRT)

Trial Overview The study tests two training devices: the Dynamic Haptic Robotic Trainer (DHRT) and an advanced version, DHRT+. It measures how well these tools help residents learn to perform CVC insertions compared to current training methods.

How Is the Trial Designed?

Group I: Residents to receive Dynamic Haptic Robotic Training Experimental Treatment 1 Intervention

Group II: Residents to receive Advanced Dynamic Haptic Robotic Training Experimental Treatment 1 Intervention

Advanced Dynamic Haptic Robotic Trainer (DHRT+) is already approved in United States for the following indications:

Approved in United States as DHRT+ for:

• Central Venous Catheter (CVC) insertion training for surgical residents

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 163 residents practicing simulated central venous catheterization, higher rates of needle tip tracking (over 40%) and aspiration (over 80%) significantly increased the likelihood of successful venous access, reducing procedural complications.

The study highlighted that while proper tip tracking and aspiration are crucial for success, residents struggled to improve their tip tracking skills without specific feedback, indicating the importance of detailed performance assessment in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Assessment Metrics for Simulated Central Venous Catheterization Training. Brown, DC., Gonzalez-Vargas, JM., Tzamaras, HM., et al.[2023]

The Dynamic Haptic Robotic Trainer (DHRT) is an effective simulator for teaching central venous catheterization (CVC), specifically focusing on the needle insertion technique.

Implementing a hands-on instructional walkthrough improved the learnability of the DHRT, suggesting that interactive training methods can enhance the performance of learners in medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow and Steady: Examining the impact of hands-on instructions on learnability of a training simulator to enhance development of core skills in Central Venous Catheterization. Tzamaras, HM., Brown, DC., Gonzalez-Vargas, JM., et al.[2023]

Training surgical residents on a Dynamic Haptic Robotic Trainer (DHRT) for ultrasound-guided Internal Jugular Central Venous Catheterization (US-IJCVC) effectively transfers skills to clinical practice, as shown by comparable performance to those trained on traditional manikins.

There were no significant differences in procedural outcomes between DHRT-trained and manikin-trained residents, indicating that DHRT training is a valid and effective method for teaching this critical skill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the simulation center to the bedside: Validating the efficacy of a dynamic haptic robotic trainer in internal jugular central venous catheter placement. Chen, HE., Sonntag, CC., Mirkin, KA., et al.[2021]

The Dynamic Haptic Robotic Training (DHRT) system effectively distinguished between expert and novice performance in Central Venous Catheterization (CVC) by measuring key metrics such as time to complete the insertion and standard deviation of deviations (SDoD).

Novice surgeons demonstrated significant improvement in their skills, as evidenced by reduced path length and time to complete the insertion after training with the DHRT system, indicating its potential for enhancing surgical training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Haptic Simulators Distinguish Expert Performance? A Case Study in Central Venous Catheterization in Surgical Education. Chen, HE., Yovanoff, MA., Pepley, DF., et al.[2020]

The Dynamic Haptic Robotic Trainer (DHRT) aims to reduce the 39% adverse effects associated with Central Venous Catheterization (CVC) by standardizing training and providing automated performance assessments.

Expert interviews confirmed that the DHRT's assessment metrics align with real-world scenarios, as experts agree on the factors that contribute to patient case difficulty, such as anatomical variations and the complexity of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OBJECTIVE ASSESSMENT METRICS FOR CENTRAL LINE SIMULATORS: AN EXPLORATION OF CAUSAL FACTORS. Gonzalez-Vargas, JM., Brown, DC., Moore, JZ., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04541446

Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ ... Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization. What is the study measuring?

2. pure.psu.edu pure.psu.edu/en/projects/dynamic-haptic-robotic-training-for-central-venous-catheter-inser-3

Dynamic Haptic Robotic Training for Central Venous ... Project Summary/Abstract The goal of this project is to reduce the high mechanical and infectious complication rates of Central Venous Catheter (CVC) ...

3. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-05661-2

Evaluating the effects of comprehensive simulation on central ... This study evaluates the impact of the DHRT + on resident self-efficacy and CVC skill gains as compared to training on the DHRT alone.

4. sciencedirect.com sciencedirect.com/science/article/am/pii/S193172042300435X

Clinical Outcomes of Standardized Central Venous ... From the simulation center to the bedside: Validating the efficacy of a dynamic haptic robotic trainer in internal jugular central venous catheter placement.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10185707/

Evaluating the Impact of Assessment Metrics for Simulated ... The Dynamic Haptic Robotic Trainer (DHRT), allows residents to practice ultrasound guided needle insertions during simulated Central Venous Catheterization (CVC) ...

6. newswise.com newswise.com/articles/dynamic-haptic-robotic-training-to-decrease-catheter-procedure-complications

Dynamic haptic robotic training to decrease catheter ... The new project will use the team's innovative concept of dynamic haptic robotic training (DHRT), where a programmable robot is used to apply ...

7. researchgate.net researchgate.net/publication/308180403_Improving_Medical_Education_Simulating_Changes_in_Patient_Anatomy_Using_Dynamic_Haptic_Feedback

Simulating Changes in Patient Anatomy Using Dynamic ... The DHRT uses haptic robotic simulation and mock ultrasound to train residents on CVC needle insertion for multiple patient anatomies, because ...