Aspiration in Acute Respiratory Failure Survivors

NACompletedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

August 31, 2018

Study Completion Date

November 30, 2020

Conditions
Dysphagia
Interventions
PROCEDURE

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.

PROCEDURE

BSE

Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.

Trial Locations (3)

80045

University of Colorado Hospital, Aurora

06519

Yale University, New Haven

Unknown

Boston University Medical Center, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Boston University

OTHER

collaborator

National Institute of Nursing Research (NINR)

NIH

lead

University of Colorado, Denver

OTHER

NCT02363686 - Aspiration in Acute Respiratory Failure Survivors | Biotech Hunter | Biotech Hunter