Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Recruiting

• Conditions: Tracheostomy
• Interventions: Other: 3 Oz water screen

• Registration Number: NCT06120790
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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).

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Status Verified: 2024-05
• Study Start: 2024-05-06
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Tracheostomies	3 Oz water screen	Patients with openings in their airways (i.e. tracheostomies)

Primary Outcome Measures

Name	Time	Method
Swallow screen	End of participation study within 7 days of enrollment	Swallow screen measured as pass/fail for presence or absence of aspiration
Penetration Aspiration Scale Score	End of participation study within 7 days of enrollment	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States