Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
ConditionTracheostomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a tracheostomy
Able to remain alert for testing
Not on a modified diet for pre-existing dysphagia
No head of bed restrictions
Disqualifiers
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
Trial population
Patients with a tracheostomy (dysphagia).
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
3 Oz water screen
Other interventionPatient 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Patients with Tracheostomies1 intervention
Trial outcomes
Primary outcomes
1
Swallow screen
Swallow screen measured as pass/fail for presence or absence of aspiration
Time frame
End of participation study within 7 days of enrollment2
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.
Time frame
End of participation study within 7 days of enrollmentSponsors and contacts
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Source ClinicalTrials.gov