NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 632
- Locations
- 2
- Primary Endpoint
- Number of Successful first-time tracheostomy tube changes
Study Overview
Brief Summary
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.
- Experimental group 1 will receive suctionings using automated robotic suctioning device.
- Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Because blinding of participants and investigators is not practical, all groups will be aware of their respective treatment protocols, which will be considered in the analysis and interpretation of outcomes.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
Automated tracheostomy suctioning device
Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device.
Intervention: NextGen automated tracheostomy suctioning device (Device)
Mixed-reality tracheostomy tube change system
Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device.
Intervention: NextGen mixed-reality tracheostomy tube change system (Device)
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.
Intervention: NextGen Tracheostomy Toolkit (Device)
Control group
Participants in this group will receive usual tracheostomy care.
Outcomes
Primary Outcomes
Number of Successful first-time tracheostomy tube changes
Time Frame: An average of 6 weeks
successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.
Percent of Successful Atraumatic suctionings
Time Frame: An average of 6 weeks
successful first-time tracheostomy tube change attempt, will be calculated by measuring the number of successful first-time tracheostomy tube change attempts over the total number of tracheostomy tube change attempts; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.
Secondary Outcomes
- Occurrence of Airway Obstruction(An average of 6 weeks)
- Intensive care unit length of stay (LOS)(An average of 6 weeks)
- Occurrence of Tracheostomy tube dislodgments(During procedure up to 6 weeks)
- Occurrence of False tract(During procedure)
- Patient/family acceptability(Immediately after procedure)
- Equitable delivery of care as assessed by summary of demographic factors(Immediately after procedure)
- Occurrence of airway bleeding complications(During tracheostomy suctionings)
- Occurrence of Ventilator-associated pneumonia(An average of 6 weeks)
- Patient/family satisfaction(Immediately after procedure)
- Duration of mechanical ventilation(Approximately 2 weeks)
- Tracheostomy duration(An average of 6 weeks)
- Discomfort as assessed by a Visual Analog Pain Scale(During tracheostomy suctioning)
- Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale(During tracheostomy suctioning)
- Occurrence of Stomal Infection(At time of receiving tracheostomy up to approximately 6 weeks)
- Hospital length of stay(An average of 6 weeks)