CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
FEES +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02363686
NCT02363686N/ACompleted
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Aspiration in Acute Respiratory Failure Survivors

University of Colorado, Denver·interventional·Posted Feb 16, 2015·Updated Jul 12, 2021

In Brief

A clinical study evaluating FEES and BSE for Dysphagia. Completed, enrolled 248 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysphagia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Boston University, National Institute of Nursing Research (NINR)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2015
Enrollment StartFeb 1, 2012
Primary CompletionAug 31, 2018
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 11.4 years ago

Interventions

FEESprocedure

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.

BSEprocedure

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.