Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Mount Sinai Health System

Status: Enrolling

Conditions: Tracheostomy

Treatments: Other: 3 Oz water screen

Study type: Observational

Funder types: Other

Identifiers

NCT06120790

STUDY-23-00005

Details and patient eligibility

About

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).

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Patients with Tracheostomies

Description:

Patients with openings in their airways (i.e. tracheostomies)

Treatment:

Other: 3 Oz water screen