NextGen Toolkit for Tracheostomy Care

(TRACHEAS Trial)

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

632 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are: * What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group? * What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system. 4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.

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.

Is the NextGen Toolkit for Tracheostomy Care safe for humans?

The Global Tracheostomy Collaborative (GTC) has been working to improve safety in tracheostomy care by collecting data on patient outcomes and identifying risks, such as the link between bleeding and mortality. This suggests that efforts are being made to enhance safety in tracheostomy care, but specific safety data for the NextGen Toolkit itself is not provided. ^{1 2 3 4 5}

How is the Tracheostomy Robotics treatment different from other tracheostomy care options?

Tracheostomy Robotics is unique because it uses robotic technology to enhance tracheostomy care, potentially allowing for more precise and early interventions in the healing process. This approach may improve wound management and shorten recovery time compared to traditional methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Cutting-edge Health Education, Tracheostomy Robotics in the NextGen Toolkit for Tracheostomy Care clinical trial?

Research shows that improving tracheostomy care through education and standardized protocols can reduce complications and improve patient outcomes. Quality improvement programs and systematic assessment tools have been effective in enhancing the safety and coordination of tracheostomy care. ^{6 11 12 13 14}

Who Is on the Research Team?

Michael J Brenner, MD, FACS

Principal Investigator

University of Michigan

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

Principal Investigator

Johns Hopkins University School of Nursing

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

Quality improvement in tracheostomy care: A multidisciplinary approach to standardizing tracheostomy care to reduce complications. [2020]

2. Qatar pubmed.ncbi.nlm.nih.gov

Tracheostomy Practice Questionnaire: Development of a Valid and Reliable Tool for Assessing Tracheostomy Practice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

Tracheostomy clinical practices and patient outcomes in three tertiary metropolitan hospitals in Australia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

The Global Tracheostomy Collaborative: one institution's experience with a new quality improvement initiative. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. [2020]

8. England pubmed.ncbi.nlm.nih.gov

The Trach Safe Initiative: A Quality Improvement Initiative to Reduce Mortality among Pediatric Tracheostomy Patients. [2020]

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

Respiratory Practices in the Long-term Care Setting: A Human Factors-Based Risk Analysis. [2021]

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

A standardized, closed-loop system for monitoring pediatric tracheostomy-related adverse events. [2019]

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

Assessing Competence With a Task Trainer: Validity Evidence for Novel Tracheostomy Care Skills Assessment Tool. [2023]

12. Belgium pubmed.ncbi.nlm.nih.gov

Tool for assessing surgical tracheostomy skills in otolaryngology residents. [2016]

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

Product development for weaning in respiratory care. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Incentive spirometry for the tracheostomy patient. [2012]