Evaluating a 3 oz water protocol for patients with tracheostomies
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
This study is testing a new 3 oz water swallowing test for patients with tracheostomies to see if it can better identify those at risk of choking compared to standard swallow tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06120790 on ClinicalTrials.gov |
What this trial studies
This research examines the effectiveness of a 3 oz water screening protocol for patients with tracheostomies, comparing it to traditional instrumental swallow assessments like the Flexible Endoscopic Evaluation of the Swallow and the Modified Barium Swallow Study. The study aims to identify patients at risk of aspiration, which can occur when food or liquid enters the lungs during eating or drinking. By utilizing this novel protocol, clinicians may gain valuable insights into the swallowing capabilities of these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a tracheostomy and are alert during testing.
Not a fit: Patients who do not have a tracheostomy or those who are unable to remain alert for testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could provide a simpler and more effective screening method for aspiration risk in patients with tracheostomies.
How similar studies have performed: While this approach is novel for tracheostomy patients, similar screening protocols have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Miguel Escalon — Icahn School of Medicine at Mount Sinai
- Study coordinator: Beth Kraus
- Email: Beth.Kraus@MountSinai.org
- Phone: 212-241-3387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.