Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Tracheostomy Clinical Trial

Official title:

Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120790
• Other study ID #: STUDY-23-00005
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Beth Kraus
• Phone: 212-241-3387
• Email: Beth.Kraus[@]MountSinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swallow screen	Swallow screen measured as pass/fail for presence or absence of aspiration	End of participation study within 7 days of enrollment
Primary	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