Aspiration in Acute Respiratory Failure Survivors 2

NARecruitingINTERVENTIONAL
Enrollment

855

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

December 15, 2025

Study Completion Date

December 15, 2025

Conditions
DysphagiaAspiration
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

Trial Locations (5)

80045

RECRUITING

University of Colorado, Aurora

94305

RECRUITING

Stanford Univerity, Stanford

06519

RECRUITING

Yale University, New Haven

02111

RECRUITING

Tufts Medical Center, Boston

02118

RECRUITING

Boston University, Boston

All Listed Sponsors
collaborator

National Institute of Nursing Research (NINR)

NIH

lead

University of Colorado, Denver

OTHER