Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-06

Study Completion Date

2027-10-31

Brief Summary

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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).

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Detailed Description

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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

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Tracheostomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Tracheostomies

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

3 Oz water screen

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No