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Could a 3 oz water test replace complex swallow exams for tracheostomy patients?

NCT ID NCT06120790

Diagnosis Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study is testing whether a simple 3-ounce water swallow test can accurately detect aspiration (liquid entering the airway) in people with tracheostomies. Researchers will compare the results of this quick bedside test with the current gold-standard methods (a camera through the nose or a special X-ray). The goal is to see if the water test is a reliable, easier way to screen swallowing safety. The study plans to enroll 80 adults with tracheostomies.

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 simple water test could become a quick, bedside screening tool to check swallowing safety in tracheostomy patients, reducing the need for more complex procedures.
What could go wrong
This is a small, early-stage study (80 participants) testing a screening method, not a treatment. The test may not be accurate enough to replace standard assessments, 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 80 people

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

Started

May 2024

Expected to finish

Oct 2027

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

Patients with a tracheostomy (dysphagia).

Ages

18 years and older

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: * Has a tracheostomy * Able to remain alert for testing * Not on a modified diet for pre-existing dysphagia * No head of bed restrictions * Not NPO by physician for any reason other than possible dysphagia * At least 18 years old Exclusion Criteria: * Does not have a tracheostomy * Unable to remain alert for testing * On a modified diet due to pre-existing dysphagia * Head of bed restrictions for greater than or equal to 30 degrees * NPO by physician for reasons other than possible dysphagia * Less than 18 years old

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As listed by the trial registrant

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

Tracheostomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

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