Tracheostomy
Conditions
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).
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
OTHER3 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactBeth Kraus
Outcome results
None listed