RecruitingNot ApplicableNCT05108896

Aspiration in Acute Respiratory Failure Survivors 2

Aspiration in Acute Respiratory Failure Survivors


Sponsor

University of Colorado, Denver

Enrollment

855 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 3-Screenings Protocol, FEES, and others for people with aspiration and dysphagia. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST3-Screenings Protocol

The 3-Screenings Protocol is a modified bedside swallow exam (BSE) consisting of a study developed five-item decision tree algorithm including voice quality assessment and a 2-ounce water consistency assessment, the Yale Swallow Test, with a scored 3-ounce Water Swallow Test (3-WST), and the Toronto Bedside Swallowing Screening Test (TOR-BSST).

DIAGNOSTIC_TESTFEES

A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.

DIAGNOSTIC_TESTTracheal Ultrasound

Ultrasound imaging of the trachea, measuring tracheal diameter and endotracheal tube (ETT) size ratio within 72 hours prior to extubation


Locations(5)

Stanford Univerity

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston University

Boston, Massachusetts, United States

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NCT05108896


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