Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety (TRACHEAS)

Johns Hopkins University

Status: Begins enrollment in a year or more

Conditions: Tracheostomy

Treatments: Device: NextGen mixed-reality tracheostomy tube change system; Device: NextGen Tracheostomy Toolkit; Device: NextGen automated tracheostomy suctioning device

Study type: Interventional

Funder types: Other

Identifiers

NCT06236542

IRB00430139

Details and patient eligibility

About

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.

Enrollment: 632 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult patients 18 years or older
• those who received a tracheostomy during their hospital stay
• those who were admitted to the hospital with a tracheostomy

Exclusion criteria

• none

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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632 participants in 4 patient groups

Automated tracheostomy suctioning device

Experimental group

Description:

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

Treatment:

Device: NextGen automated tracheostomy suctioning device

Mixed-reality tracheostomy tube change system

Experimental group

Description:

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

Treatment:

Device: NextGen mixed-reality tracheostomy tube change system

NextGen Tracheostomy Toolkit

Experimental group

Description:

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.

Treatment:

Device: NextGen Tracheostomy Toolkit

Control group

No Intervention group

Description:

Participants in this group will receive usual tracheostomy care.