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

NCT01011803 | Completed

• 1 other identifier: 09-004079-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Deglutition; Phonation

Outcome Measures

Primary Outcomes (1)

• Ability of combined speech score to predict moderate to severe MBS/FEES Dysphagia

  Associations between measures of speech functions and ordinal measures of swallowing function will be examined by estimating Pearson's correlation coefficient. Categorical variables will be summarized with number and percentage.

  24 hours

Secondary Outcomes (1)

• Ability of each individual speech score to predict MBS/FEES Dysphagia

  24 hours

Study Arms (1)

Combined speech therapy tools, measures of swallowing function

EXPERIMENTAL

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).

Other: Combined speech therapy tools, measures of swallowing function

Interventions

Combined speech therapy tools, measures of swallowing function OTHER

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).

Combined speech therapy tools, measures of swallowing function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Study Officials

• Emir Festic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)