Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3 Oz water screen.
- Who it may be relevant to
- Registry conditions: Tracheostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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.
Primary outcome measures
- Swallow screen [Time frame: End of participation study within 7 days of enrollment]
- Penetration Aspiration Scale Score [Time frame: End of participation study within 7 days of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Mount Sinai Hospital — New York
Identifiers
NCT: NCT06120790 · STUDY-23-00005