TracheostomyNCT06120790
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
An observational study of Tracheostomy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- 3 Oz water screen
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a tracheostomy (dysphagia).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Beth Kraus, 212-241-3387, Beth.Kraus@MountSinai.org
About this study
Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).
Read the detailed description
The purpose of this research study is to determine if a 3 oz water screening protocol is an effective screen for patients with openings in their airways (i.e. tracheostomies). This procedure is already in use for many different populations and is particularly useful for clinicians who want to understand who is at risk for having food or liquid enter the lungs while eating or drinking (i.e. aspiration).
- Conditions
- Tracheostomy
- Being tested
- 3 Oz water screen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Oz water screenOther
Patient will consume 3 oz of water continuously without stopping and then will be monitored for one minute post completion. Patient will complete this twice in the same session.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Tracheostomies | Patients with openings in their airways (i.e. tracheostomies) Receives: Other: 3 Oz water screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallow screen
Swallow screen measured as pass/fail for presence or absence of aspiration
Measured: End of participation study within 7 days of enrollment
Penetration Aspiration Scale Score
The penetration aspiration scale (PAS) is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The PAS is an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Higher scores indicate better health outcomes.
Measured: End of participation study within 7 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 May 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Escalon, Icahn School of Medicine at Mount Sinai
- Investigators
- Miguel Escalon, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120790
- Sponsor's protocol ID
- STUDY-23-00005
- Status last verified
- Sep 2025
- First submitted
- 1 Nov 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.