Study Results
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View full resultsBasic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2012-02-29
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FEES & Bedside Swallow Evaluation (BSE)
Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE).
FEES
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.
BSE
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.
Interventions
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FEES
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.
BSE
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Admission to a University of Colorado Hospital ICU
2. Mechanical ventilation support through an endotracheal tube for greater than 24 hours
Exclusion Criteria
1. Age less than 18 years
2. Contraindication to enteral nutrition administration
3. Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder)
4. Pre-existing dysphagia
5. Previous surgery of the head, neck, or esophagus
6. Previous cancer of the head or neck
7. The presence of a tracheostomy
8. The presence of nasal or pharyngeal trauma or bleeding
9. Clinical team believes one of the protocols would be harmful to an individual patient
10. Expected survival less than 3 months
11. Pregnancy
12. Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period
13. Inability to give informed consent and proxy unavailable.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Boston University
OTHER
National Institute of Nursing Research (NINR)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Marc Moss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Boston University Medical Center
Boston, Massachusetts, United States
Countries
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References
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Macht M, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Postextubation dysphagia is persistent and associated with poor outcomes in survivors of critical illness. Crit Care. 2011;15(5):R231. doi: 10.1186/cc10472. Epub 2011 Sep 29.
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American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
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Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6.
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Langmore SE, Krisciunas GP, Warner H, White SD, Dvorkin D, Fink D, McNally E, Scheel R, Higgins C, Levitt JE, McKeehan J, Deane S, Siner JM, Vojnik R, Moss M. Correction to: Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure. Dysphagia. 2021 Oct;36(5):842-853. doi: 10.1007/s00455-020-10226-8. No abstract available.
Langmore SE, Krisciunas GP, Warner H, White SD, Dvorkin D, Fink D, McNally E, Scheel R, Higgins C, Levitt JE, McKeehan J, Deane S, Siner JM, Vojnik R, Moss M. Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure. Dysphagia. 2021 Oct;36(5):831-841. doi: 10.1007/s00455-020-10199-8. Epub 2020 Nov 6.
Krisciunas GP, Langmore SE, Gomez-Taborda S, Fink D, Levitt JE, McKeehan J, McNally E, Scheel R, Rubio AC, Siner JM, Vojnik R, Warner H, White SD, Moss M. The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors. Crit Care Med. 2020 Nov;48(11):1604-1611. doi: 10.1097/CCM.0000000000004554.
Moss M, White SD, Warner H, Dvorkin D, Fink D, Gomez-Taborda S, Higgins C, Krisciunas GP, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Vojnik R, Langmore SE. Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors. Chest. 2020 Nov;158(5):1923-1933. doi: 10.1016/j.chest.2020.07.051. Epub 2020 Jul 25.
Lynch YT, Clark BJ, Macht M, White SD, Taylor H, Wimbish T, Moss M. The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. J Crit Care. 2017 Jun;39:143-148. doi: 10.1016/j.jcrc.2017.02.013. Epub 2017 Feb 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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