Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06236542
Status
Not Yet Recruiting

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Conditions

  • Tracheostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • NextGen automated tracheostomy suctioning device — DEVICE
    Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctionings using an automated robotic suctioning device.
  • NextGen mixed-reality tracheostomy tube change system — DEVICE
    Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy tube changes using the mixed reality tracheostomy tube change system.
  • NextGen Tracheostomy Toolkit — DEVICE
    Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctioning using the robotic suctioning device; and tracheostomy tube changes using the mixed reality tracheostomy tube change system.

Study Details

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.

Key Dates

Start date
Oct 1, 2027
Status verified
Jan 2024
Primary completion
Jun 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
632 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Automated tracheostomy suctioning device
    Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device.
  • Experimental: Mixed-reality tracheostomy tube change system
    Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device.
  • Experimental: NextGen Tracheostomy Toolkit
    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.
  • No Intervention: Control group
    Participants in this group will receive usual tracheostomy care.

Primary Outcome Measure

Number of Successful first-time tracheostomy tube changes [ Time Frame: An average of 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC
[email protected]
443-655-3482
Axel Mathias, PhD (SUB_INVESTIGATOR)
Mathias Unberath, PhD (SUB_INVESTIGATOR)
University of MichiganAnn ArborMichigan48104
Michael J Brenner, MD, FACS
[email protected]
734-369-0204
Michael J Brenner, MD, FACS (PRINCIPAL_INVESTIGATOR)

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