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NCT06236542 · ClinicalTrials.gov registry record · NA
Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
A NA study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- NA
- Development phase
- 632
- Enrollment target
NCT06236542: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT06236542 is a NA study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 632 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06236542, a NA study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 632 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- DEVICE NextGen automated tracheostomy suctioning device
- DEVICE NextGen mixed-reality tracheostomy tube change system
- DEVICE NextGen Tracheostomy Toolkit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 632 participants |
| Start Date | 2027-10-01 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
What is known before NCT06236542 opens enrollment
NCT06236542 is an interventional study that assigns participants to a tested intervention. The registered 632 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which NextGen automated tracheostomy suctioning device is the first listed.
NCT06236542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06236542 about?
NCT06236542 is a clinical study titled "Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety". 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 n...
What is the current status of trial NCT06236542?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 632 participants. The study started on 2027-10-01. Estimated completion is 2029-09-30.
What interventions are being tested in trial NCT06236542?
The interventions under investigation include: NextGen automated tracheostomy suctioning device (DEVICE), NextGen mixed-reality tracheostomy tube change system (DEVICE), NextGen Tracheostomy Toolkit (DEVICE).
Who is sponsoring clinical trial NCT06236542?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06236542's enrollment target sits among peer trials
632 159th of 2000 higher than 1,842 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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