NCT06120790 Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
| NCT ID | NCT06120790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Tracheostomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-05-06 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Miguel Escalon
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06120790 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tracheostomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06120790 currently recruiting?
Yes, NCT06120790 is actively recruiting participants. Contact the research team at Beth.Kraus@MountSinai.org for enrollment information.
Where is the NCT06120790 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06120790 clinical trial?
NCT06120790 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Miguel Escalon at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 80 participants.