Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating a 3 oz water protocol for patients with tracheostomies

Official title: Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Run by Icahn School of Medicine at Mount Sinai · NCT06120790 · Data updated 2026-11-12

This study is testing a new 3 oz water swallowing test for patients with tracheostomies to see if it can better identify those at risk of choking compared to standard swallow tests.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedMay 6, 2024
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedSeptember 8, 2025
Trial IDNCT06120790 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who have a tracheostomy and are alert during testing.

Probably not a fit

Patients who do not have a tracheostomy or those who are unable to remain alert for testing will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research examines the effectiveness of a 3 oz water screening protocol for patients with tracheostomies, comparing it to traditional instrumental swallow assessments like the Flexible Endoscopic Evaluation of the Swallow and the Modified Barium Swallow Study. The study aims to identify patients at risk of aspiration, which can occur when food or liquid enters the lungs during eating or drinking. By utilizing this novel protocol, clinicians may gain valuable insights into the swallowing capabilities of these patients.

Why it matters

Potential benefit: If successful, this protocol could provide a simpler and more effective screening method for aspiration risk in patients with tracheostomies.

How similar studies have gone: While this approach is novel for tracheostomy patients, similar screening protocols have shown promise in other populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Mount Sinai Hospital
    New York, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.