Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study
Completed · Not applicable
Conditions studied: Aspiration
In brief
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.
Key facts
- Study ID
- NCT01011803
- Run by
- Mayo Clinic
- People needed
- 60
- Starts
- 2009-11-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2013-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients admitted to the ICU, deemed at risk for aspiration, who require FEES and MBS per speech therapy evaluation.
- Ability to follow commands, read English language, vocalize and complete a predefined phonation test and the DAST.
- Patients are able to undergo formal swallow evaluation by FEES and/or MBS.
You may not qualify if…
- Patients who have had any type of head and neck surgery.
- Patients that cannot read or talk, or speak/understand English language.
- Patients with delirium, disorientation, unable to follow commands.
- Patients with gastric tubes, tracheostomy or strict order for nothing by mouth.
- Coagulation disorder that is prohibitive for FEES (platelets <50, 000, ongoing or uncontrolled bleeding, international normalized ratio (INR)> 1.5, activated partial thromboplastin time (aPTT) greater than 1.5 times normal value).
- Patients that cannot sit up at 90 degrees for MBS.
Where it is running
- Mayo Clinic Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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