DHRT Training Devices for Central Venous Catheter Placement Skills

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

625 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Advanced Dynamic Haptic Robotic Trainer (DHRT+) for Central Venous Catheter Placement Skills?

Research shows that the Dynamic Haptic Robotic Trainer (DHRT) helps improve skills in central venous catheterization by providing detailed feedback and assessment, reducing the need for a preceptor, and standardizing training. It has been validated to effectively transfer skills from simulation to real clinical environments, enhancing the learning experience and skill development. ^{1 2 3 4 5}

Is the DHRT system safe for use in humans?

The DHRT system is designed to improve training for central venous catheterization, which can reduce the risk of complications during the procedure. However, the safety of the DHRT system itself in humans has not been specifically addressed in the available research. ^{1 2 3 4 5}

How is the DHRT treatment for central venous catheter placement unique?

The DHRT treatment is unique because it uses a dynamic simulator to mimic different patient anatomies, providing automated feedback and standardized training for central venous catheter placement, unlike traditional static simulators that only represent a single patient configuration. ^{1 2 3 4 5}

Research Team

Jason Z. Moore, Ph.D.

Principal Investigator

Penn State University

Scarlett R Miller, Ph.D.

Principal Investigator

Penn State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Can Haptic Simulators Distinguish Expert Performance? A Case Study in Central Venous Catheterization in Surgical Education. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Assessment Metrics for Simulated Central Venous Catheterization Training. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

OBJECTIVE ASSESSMENT METRICS FOR CENTRAL LINE SIMULATORS: AN EXPLORATION OF CAUSAL FACTORS. [2021]

4. United States 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. [2021]

5. United States 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. [2023]