Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

ConditionTracheostomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJohns Hopkins University

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

none

Trial design

Treatments tested in this trial

  • NextGen automated tracheostomy suctioning device
  • NextGen mixed-reality tracheostomy tube change system
  • NextGen Tracheostomy Toolkit

Treatment groups

632 Participants
are divided into 4 treatment groups

Sponsors and collaborators