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RECRUITING
NCT05108896
NA

Aspiration in Acute Respiratory Failure Survivors 2

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

Official title: Aspiration in Acute Respiratory Failure Survivors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

855

Start Date

2021-12-15

Completion Date

2025-12-15

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

3-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_TEST

FEES

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_TEST

Tracheal 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