Actively Recruiting
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-08
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a 3 oz water screening protocol in patients with tracheostomies. This observational study aims to compare this screening method to established instrumental swallow assessments, such as the Flexible Endoscopic Evaluation of the Swallow and the Modified Barium Swallow Study, to identify risks of aspiration during eating or drinking. The study is sponsored by the Icahn School of Medicine at Mount Sinai and focuses on patients with airway openings called tracheostomies. Participants will undergo the 3 oz water screen, where they will drink 3 oz of water continuously twice during the same session and be monitored for one minute after each drinking. The study does not involve any experimental treatments but observes how well this screening protocol works compared to the gold standard swallow tests. During the study, participants will be assessed using swallow screens and the Penetration Aspiration Scale score within seven days of enrollment. The study includes monitoring alertness and diet status, with no modifications or restrictions imposed beyond usual care. Participation involves observation and assessment to better understand swallowing safety in people with tracheostomies, with the study expected to continue until October 2027.
CONDITIONS
Brief Title
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session within 7 days of enrollment
Participants undergo a 3 oz water screening protocol where they consume water continuously twice in the same session and are monitored for one minute after each consumption to assess swallowing safety.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
B
Beth Kraus
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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