Status:

RECRUITING

Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Conditions:

Tracheostomy

Eligibility:

All Genders

18+ years

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 M...

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 alread...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 6 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06120790

Start Date

May 6 2024

End Date

October 1 2027

Last Update

September 8 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Mount Sinai Hospital

New York, New York, United States, 10029