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Procedure

Mixed-reality tracheostomy tube change system for Tracheostomy Care (TRACHEAS Trial)

N/A

Waitlist Available

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

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Those who received a tracheostomy during their hospital stay

Those who were admitted to the hospital with a tracheostomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 6 weeks

Awards & highlights

TRACHEAS Trial Summary

This trial aims to test a new toolkit called NextGen Tracheostomy Toolkit in people who have undergone a tracheostomy. The trial will compare different groups of participants to see the effect of

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort or complications during suctioning or tube changes such as bleeding, infection risk increase due to equipment use, and possible technical issues with the new devices leading to interrupted care.

TRACHEAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a tracheostomy during my hospital stay.

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I was hospitalized and had a tracheostomy.

TRACHEAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Successful first-time tracheostomy tube changes

Percent of Successful Atraumatic suctionings

Secondary outcome measures

Discomfort as assessed by a Visual Analog Pain Scale

Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale

Duration of mechanical ventilation

+12 more

TRACHEAS Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: NextGen Tracheostomy ToolkitExperimental Treatment1 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 systemExperimental Treatment1 Intervention

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

Group III: Automated tracheostomy suctioning deviceExperimental Treatment1 Intervention

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

Group IV: Control groupActive Control1 Intervention

Participants in this group will receive usual tracheostomy care.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,043 Total Patients Enrolled

Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BCPrincipal InvestigatorJohns Hopkins University School of Nursing

Michael J Brenner, MD, FACSPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this medical study?

"To be considered for participation in this research study, individuals must require tracheostomy care and fall within the age range of 18 to 100. The trial is currently accepting approximately 632 potential participants."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"According to the information provided by clinicaltrials.gov, this particular clinical trial is not currently seeking participants. The trial was initially posted on October 1st, 2027 and last updated on January 24th, 2024. However, it's worth noting that there are four other ongoing clinical trials actively recruiting patients at the moment."

Answered by AI

Is the age criterion inclusive of individuals who have surpassed 70 years?

"As per the eligibility requirements outlined in this clinical trial, individuals between the ages of 18 and 100 are eligible for participation."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary aim of this trial is to assess the percentage of successful atraumatic suctionings within an average duration of 6 weeks. Secondary objectives include evaluating tracheostomy duration, which refers to the length of time that the tracheostomy tube remains in place indicating dependence on tracheostomy; hospital length of stay, defined as the number of days spent in the hospital with a tracheostomy tube from insertion until discharge or removal; and identification and assessment of false tract occurrence during tracheostomy tube change procedure using various diagnostic methods such as capnography, pulsoximetry, and radiological findings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

2027. "Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236542.