NCT06120790

Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
OTHER	3 Oz water screen	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.

Timeline

• Start date: 2024-05-06
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-11-07
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States