Recruiting

Water Protocol

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06120790

Conditions

Tracheostomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3 Oz water screen

Study Details

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).

Conditions

Tracheostomy

Study ID

NCT06120790

Start date

May 6, 2024

Status verified date

Sep, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Tracheostomies

Patients with openings in their airways (i.e. tracheostomies)

Interventions

3 Oz water screen

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.

Primary outcome measure

  • Swallow screen [ Time Frame: End of participation study within 7 days of enrollment ]
  • Penetration Aspiration Scale Score [ Time Frame: End of participation study within 7 days of enrollment ]

Central Contacts and Locations

Central contacts

Beth Kraus

212-241-3387Beth.Kraus@MountSinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Beth Kraus

212-241-3387Beth.Kraus@MountSinai.org

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-09-08.