Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Recruiting now

Conditions studied: Tracheostomy

In brief

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).

Key facts

Study ID

NCT06120790

Run by

Icahn School of Medicine at Mount Sinai

People needed

80

Starts

2024-05-06

Expected to finish

2027-10-01

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 is running

• Mount Sinai Hospital — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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