AspirationNCT01011803
Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study
A study testing Combined speech therapy tools, measures of swallowing function in people with Aspiration, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration
- What is being tested?
- Combined speech therapy tools, measures of swallowing function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aspiration is defined as entry of a solid or liquid material into the respiratory tract, below the vocal folds, or inhalation of fumes and vapors. Aspiration pneumonia is an infectious process caused by aspirated oropharyngeal flora, while aspiration pneumonitis is caused by a direct chemical insult due to the aspirated material.
Aspiration pneumonitis and pneumonia among hospitalized patients result in increased morbidity, mortality and utilization of resources, with increased costs of care. Early identification of patients at risk for aspiration is crucial to prevent this preventable and often iatrogenic condition.
In general, the most common predisposing factors for aspiration in adults are alcoholism, stroke, neuromuscular disorders, seizures, and loss of consciousness, and these patients are usually cared for in the ICU setting. Furthermore, critically ill patients are also at risk as they are frequently under varying degrees of sedation, especially early in the post extubation period. Postoperative patients in addition may have prolonged functional dysphagia due to lingering effect of neuromuscular blocking agents. However, risks of aspiration may apply to any hospitalized patient and further studies with broader inclusion criteria will be needed based on the preliminary results of this pilot study.
There are multiple tools to assess for risk of aspiration in the ICU. These include Dysphagia Admission Screening Tool (DAST), Fiberoptic Endoscopic Evaluation of the Swallow (FEES) and Modified Barium Swallow (MBS), which are routinely performed at our institution. The DAST is relatively novel screening tool, brought up as an early method for identification of dysphagia, as mandated by Joint Commission. This test has not been yet validated. It was created in 2004 in order to reduce the risk of aspiration among new stroke patients, based upon literature review, research and a strong foundation of knowledge and experience in Speech-Language Pathology in evaluating dysphagia. The FEES and MBS are time consuming, often delayed and involve advanced testing that is performed by a certified speech-language pathologist and/or radiologist. MBS also requires transport of the patient from the ICU to the radiology suite and back. These tests examine function of swallow mechanism in order to predict individual patient's risk of aspiration. They are reported as pass or fail and graded from 1-8, depending on the degree of the bolus penetration into the airway and/or expulsion from the airway. The current "gold standard" to determine the risk of aspiration is considered to be MBS.
We hypothesize that among critically ill, impairments in phonation correlate significantly to impairments in deglutition. Since in current practice patient's risk for aspiration is judged based on swallowing ability, strong correlation between impairments in speech and swallow mechanisms may allow prognostication based on phonation assessment alone. As the phonetic evaluation is simple, bedside test, it may result in earlier identification of the patient at risk for aspiration and obviate need for additional, invasive and expensive tests, and additional staff utilization for patient transport, testing and interpretation.
- Conditions
- Aspiration
- Being tested
- Combined speech therapy tools, measures of swallowing function
- Keywords
- Deglutition, Phonation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined speech therapy tools, measures of swallowing functionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Combined speech therapy tools, measures of swallowing function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
Ability of each individual speech score to predict 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspirationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Emir Festic, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011803
- Sponsor's protocol ID
- 09-004079-05
- Status last verified
- Jul 2013
- First submitted
- 9 Nov 2009
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study
- ClinicalTrials.gov ID
- NCT01011803
- Acronym / sponsor ID
- 09-004079-05
- Conditions
- Aspiration
- Keywords
- Deglutition, Phonation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aspiration is defined as entry of a solid or liquid material into the respiratory tract, below the vocal folds, or inhalation of fumes and vapors. Aspiration pneumonia is an infectious process caused by aspirated oropharyngeal flora, while aspiration pneumonitis is caused by a direct chemical insult due to the aspirated material.
Aspiration pneumonitis and pneumonia among hospitalized patients result in increased morbidity, mortality and utilization of resources, with increased costs of care. Early identification of patients at risk for aspiration is crucial to prevent this preventable and often iatrogenic condition.
In general, the most common predisposing factors for aspiration in adults are alcoholism, stroke, neuromuscular disorders, seizures, and loss of consciousness, and these patients are usually cared for in the ICU setting. Furthermore, critically ill patients are also at risk as they are frequently under varying degrees of sedation, especially early in the post extubation period. Postoperative patients in addition may have prolonged functional dysphagia due to lingering effect of neuromuscular blocking agents. However, risks of aspiration may apply to any hospitalized patient and further studies with broader inclusion criteria will be needed based on the preliminary results of this pilot study.
There are multiple tools to assess for risk of aspiration in the ICU. These include Dysphagia Admission Screening Tool (DAST), Fiberoptic Endoscopic Evaluation of the Swallow (FEES) and Modified Barium Swallow (MBS), which are routinely performed at our institution. The DAST is relatively novel screening tool, brought up as an early method for identification of dysphagia, as mandated by Joint Commission. This test has not been yet validated. It was created in 2004 in order to reduce the risk of aspiration among new stroke patients, based upon literature review, research and a strong foundation of knowledge and experience in Speech-Language Pathology in evaluating dysphagia. The FEES and MBS are time consuming, often delayed and involve advanced testing that is performed by a certified speech-language pathologist and/or radiologist. MBS also requires transport of the patient from the ICU to the radiology suite and back. These tests examine function of swallow mechanism in order to predict individual patient's risk of aspiration. They are reported as pass or fail and graded from 1-8, depending on the degree of the bolus penetration into the airway and/or expulsion from the airway. The current "gold standard" to determine the risk of aspiration is considered to be MBS.
We hypothesize that among critically ill, impairments in phonation correlate significantly to impairments in deglutition. Since in current practice patient's risk for aspiration is judged based on swallowing ability, strong correlation between impairments in speech and swallow mechanisms may allow prognostication based on phonation assessment alone. As the phonetic evaluation is simple, bedside test, it may result in earlier identification of the patient at risk for aspiration and obviate need for additional, invasive and expensive tests, and additional staff utilization for patient transport, testing and interpretation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined speech therapy tools, measures of swallowing function | Experimental | Other: Combined speech therapy tools, measures of swallowing functionAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined speech therapy tools, measures of swallowing functionAll 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 |
Primary outcome
Ability of combined speech score to predict moderate to severe MBS/FEES Dysphagia
Time frame: 24 hours
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.
1 secondary outcome
Ability of each individual speech score to predict MBS/FEES Dysphagia
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Festic, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined speech therapy tools, measures of swallowing function in people with Aspiration, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of combined speech score to predict moderate to severe MBS/FEES Dysphagia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.