Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06120790
Status
Recruiting

Conditions

  • Tracheostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
May 6, 2024
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Patients with Tracheostomies
    Patients with openings in their airways (i.e. tracheostomies)

Primary Outcome Measure

Swallow screen [ Time Frame: End of participation study within 7 days of enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Beth Kraus
212-241-3387

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