Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Tracheostomies Patients with openings in their airways (i.e. tracheostomies) |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has a tracheostomy
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Able to remain alert for testing
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Not on a modified diet for pre-existing dysphagia
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No head of bed restrictions
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Not NPO by physician for any reason other than possible dysphagia
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At least 18 years old
Exclusion Criteria:
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Does not have a tracheostomy
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Unable to remain alert for testing
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On a modified diet due to pre-existing dysphagia
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Head of bed restrictions for greater than or equal to 30 degrees
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NPO by physician for reasons other than possible dysphagia
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Less than 18 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai Hospital | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Miguel Escalon, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-23-00005