Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

NCT06120790 | Recruiting

• 1 other identifier: STUDY-23-00005
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Swallow screen

  Swallow screen measured as pass/fail for presence or absence of aspiration

  End of participation study within 7 days of enrollment

• Penetration Aspiration Scale Score

  The penetration aspiration scale (PAS) is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The PAS is an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Higher scores indicate better health outcomes.

  End of participation study within 7 days of enrollment

Study Arms (1)

Patients with Tracheostomies

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

Other: 3 Oz water screen

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.

Patients with Tracheostomies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a tracheostomy (dysphagia).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Study Officials

• Miguel Escalon

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Kraus

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: May 6, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Proposals should be directed to miguel.escalon@mountsinai.org.

Locations

US (1)