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Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study

NCT01011803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-07-11

No results posted yet for this study

Summary

Swallowing implies the appropriate use and sufficient function of specific muscles that are also used in speech. Theoretically, if these muscles are functionally affected then phonation and vocalization should be impaired, as well. The purpose of this study is to examine the relationship between functions of speech and risk of aspiration as defined by swallowing function, and to investigate the diagnostic potential that functions of speech may have in predicting the risk of aspiration. This could allow for earlier stratification of ICU patients for aspiration risks. Aspiration pneumonia has been reported in more than 20% of patients with health care-associated pneumonia. There are multiple tools to assess for risk of aspiration in the ICU, yet these are time consuming, often delayed and involve advanced testing that is performed by a certified speech-language pathologist and/or radiologist. A novel 3-step phonetic evaluation was created and will be implemented on ICU patients at risk for aspiration, and the results will be correlated to the standard swallowing tests. If strong correlation is found in this pilot study, then formal clinical trial will follow to confirm that the simple bed-side phonetic evaluation could allow for earlier identification of patients at risk for aspiration, and more efficient management relative to time and resources utilization.

Conditions

  • Aspiration

Interventions

OTHER

Combined speech therapy tools, measures of swallowing function

All subjects will be assessed using combined speech therapy tools and ordinal measures of swallowing function. The combined speech therapy tools were \[diadochokinesis, glottal coup, and the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)\]. The ordinal measures of swallowing function included Dysphagia Admission Screening Tool (DAST), Modified Barium Swallow (MBS), and Fiberoptic Endoscopic Evaluation of the Swallow (FEES).

Sponsors & Collaborators

Principal Investigators

  • Emir Festic, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011803 on ClinicalTrials.gov