NextGen Toolkit for Tracheostomy Care

(TRACHEAS Trial)

Not yet recruiting at 1 trial location

Overseen By Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new toolkit designed to improve tracheostomy care. It aims to determine if advanced gadgets, such as robotic suction devices and mixed-reality systems, make suctioning and tube changes safer and more successful. Participants will be divided into groups; some will use these new tools, while others will continue with regular care. The trial seeks adults who have undergone a tracheostomy during their hospital stay. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future tracheostomy care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on tracheostomy care, so it's best to ask the trial coordinators for guidance.

What prior data suggests that the NextGen Tracheostomy Toolkit is safe for tracheostomy care?

Research has shown that the automated device for clearing tracheostomy tubes is safe to use. Studies indicate it is as safe as manual methods, with no additional risk of infections or breathing issues.

The mixed-reality system for changing tracheostomy tubes is part of the NextGen Tracheostomy Toolkit. Although specific safety data for this system is not yet available, the toolkit aims to enhance the safety and effectiveness of tracheostomy care, suggesting that safety was a key focus in its development.

Overall, the NextGen Tracheostomy Toolkit, which includes both the automated suction device and the mixed-reality system, seeks to improve tracheostomy care. This approach aims to ensure that procedures remain safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NextGen Toolkit for Tracheostomy Care because it introduces cutting-edge technology to improve patient outcomes. Unlike traditional methods that rely heavily on manual techniques, this toolkit uses mixed-reality devices for tracheostomy tube changes and automated robotic suctioning, enhancing precision and safety. The integration of virtual reality for provider training ensures consistent, high-quality care. This innovative approach not only streamlines the procedure but also has the potential to reduce complications, making tracheostomy care more efficient and effective.

What evidence suggests that this trial's treatments could be effective for tracheostomy care?

Research has shown that the mixed-reality tracheostomy tube change system, used by participants in one arm of this trial, can boost healthcare providers' confidence and skills, leading to more successful tracheostomy tube changes. Training with immersive virtual reality, part of the NextGen Tracheostomy Toolkit arm, has proven to increase familiarity and confidence among trainees, reducing anxiety during procedures. Participants in another arm will use automated tracheostomy suctioning devices, which studies indicate are safe and may lower the risk of complications like airway injury during suctioning. Evidence suggests these devices can make suctioning less traumatic and more efficient. The NextGen Tracheostomy Toolkit combines these technologies to improve tracheostomy care by standardizing procedures and using advanced tools. These innovations aim to reduce complications and enhance patient outcomes in tracheostomy care. ^{1 4 5 6 7}

Who Is on the Research Team?

Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC

Principal Investigator

Johns Hopkins University School of Nursing

Michael J Brenner, MD, FACS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have a tracheostomy, which is an opening surgically created through the neck into the windpipe to allow direct access to the breathing tube. The study will include people who are currently requiring care for their tracheostomy.

Inclusion Criteria

I had a tracheostomy during my hospital stay.

I was hospitalized and had a tracheostomy.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are divided into groups to receive different tracheostomy care interventions, including automated robotic suctioning and mixed-reality tracheostomy tube changes.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of tracheostomy-related complications and patient satisfaction.

6 weeks

Extension

Participants may continue to receive tracheostomy care interventions for extended monitoring and assessment.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cutting-edge Health Education
• Tracheostomy Robotics

Trial Overview The trial tests three interventions: an automated robotic suctioning device, a mixed-reality system for changing tracheostomy tubes, and a comprehensive NextGen Tracheostomy Toolkit that includes both devices. Participants will be randomly divided into four groups to compare these new technologies against standard tracheostomy care.

How Is the Trial Designed?

Group I: NextGen Tracheostomy Toolkit Experimental Treatment 1 Intervention

Participants in this group will receive tracheostomy care using the NextGen Tracheostomy Toolkit. Providers will be trained using virtual reality educational modules. Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device and tracheostomy tube changes using a mixed-reality tracheostomy tube change device.

Group II: Mixed-reality tracheostomy tube change system Experimental Treatment 1 Intervention

Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device.

Group III: Automated tracheostomy suctioning device Experimental Treatment 1 Intervention

Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device.

Group IV: Control group Active Control 1 Intervention

Participants in this group will receive usual tracheostomy care.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Implementing the standardized Trach Trail pathway significantly reduced the intensive care unit length of stay for patients undergoing tracheostomy, from an average of 21 days to 10 days, without increasing adverse events.

The study involved a comparison of 21 patients on the Trach Trail against 117 control patients, highlighting the effectiveness of coordinated care and education in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. Cherney, RL., Pandian, V., Ninan, A., et al.[2020]

Citations

1. trachjournal.scholasticahq.com trachjournal.scholasticahq.com/article/133583

Tracheostomy in the Digital Age: How Artificial Intelligence ... This article explores the integration of AI-driven technologies in tracheostomy education, workforce development, telehealth, predictive analytics, and robotic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06236542

Study Details | NCT06236542 | Tracheostomy Robotics ... Data regarding bleeding in the airway secretions due to injury from suctioning will be retrieved from electronic health records and automated suctioning device.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172224/

Clinical Efficacy and Safety of an Automatic Closed-Suction ... The safety outcomes included treatment-emergent adverse events (TEAEs); the complication rate (%), including hypoxemia, atelectasis, infection, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7186034/

Design and Control of a Mechatronic Tracheostomy Tube ... We introduce a novel mechatronic tracheostomy system including the development of a long suction catheter, automatic suctioning mechanisms, and relevant ...

5. jacs.or.kr jacs.or.kr/journal/view.php?number=300

Application of an Automatic Suction Device to a Patient ... The tracheostomy tube was successfully removed, and the patient was discharged. The effectiveness and safety of the A-1000 needs further study ...

6. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02126-6

Clinical trial to verify the safety of an automatic electric airway ... This study evidenced the non-inferiority of the automatic suction device to the manual method in terms of safety.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11606234/

Clinical trial to verify the safety of an automatic electric ... This study evidenced the non-inferiority of the automatic suction device to the manual method in terms of safety.