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NCT Number: NCT06120790

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).

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Swallow screen

    Time frame: End of participation study within 7 days of enrollment

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

  2. Penetration Aspiration Scale Score

    Time frame: End of participation study within 7 days of enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Kraus

CONTACT

[email protected]

212-241-3387

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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