Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

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).

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy
• Intervention / Treatment: Other: 3 Oz water screen

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 already in use for many different populations and is particularly useful for clinicians who want to understand who is at risk for having food or liquid enter the lungs while eating or drinking (i.e. aspiration).

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Beth Kraus; Phone Number: 212-241-3387; Email: Beth.Kraus@MountSinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Beth Kraus; Phone Number: 212-241-3387; Email: Beth.Kraus@MountSinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a tracheostomy (dysphagia).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Tracheostomies; Patients with openings in their airways (i.e. tracheostomies)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Miguel Escalon, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY-23-00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No