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Smartwatch tech could take the guesswork out of tracheostomy tube removal

NCT ID NCT07198425

Knowledge-focused Sponsor: Bin Zhang Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will monitor 120 tracheostomy patients using wearable devices to track physiological signals like heart rate and breathing patterns. The goal is to see if these signals can predict whether a patient will successfully have their breathing tube removed without needing it reinserted within 48 hours. Researchers hope to build a model that helps doctors make safer decisions about decannulation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, wearable-based tool to help doctors decide when it's safe to remove a tracheostomy tube, reducing failed attempts and complications.
What could go wrong
This is an early observational study, not a treatment trial. The predictive model may not be accurate enough for widespread use, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pre-decannulation rehabilitation therapy for tracheotomy patients

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years ≤ Age ≤ 90 years, non-mechanically ventilated patients. * Tracheotomy completed, ≥48 hours since cannula placement (postoperative early edema has stabilized). * Patient or legal representative has provided informed consent. Exclusion Criteria: * Recent (≤48 hours) major neck/upper airway surgery requiring avoidance of upper airway airflow impact. * Severe consciousness disorder/delirium (RASS ≤ -3 or ≥ +2), extreme anxiety/inability to cooperate. * Total laryngectomy or laryngo-tracheal separation. * Oral endotracheal intubation. * Age \<18 years, Age \> 90years. * Malignant tumor with an expected survival time ≤ 6 months. * Patients or legal representatives unable to obtain informed consent. * Known contraindications for tracheotomy decannulation. * Unable to comply with the use of wearable devices

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Physiological parameter Tracheostomy decannulation

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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