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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Tracheostomies | Patients with openings in their airways (i.e. tracheostomies) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 Oz water screen | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Swallow screen | Swallow screen measured as pass/fail for presence or absence of aspiration | End of participation study within 7 days of enrollment |
| Penetration Aspiration Scale Score | 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. | End of participation study within 7 days of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a tracheostomy (dysphagia).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Kraus | Contact | 212-241-3387 | Beth.Kraus@MountSinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Escalon | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Proposals should be directed to miguel.escalon@mountsinai.org.
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