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First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS scale [1-8]> 1), which should predispose to endotracheal aspiration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long term ventilated subjects | Muscle Strength Measurement, ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Strength Measurement | Other | MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength | We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients. | Within 24 hours of fiberoptic endoscopic evaluation of swallow |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration | Within 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Eikermann, MD, PhD | MGH, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8721066 | Background | Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897. | |
| 19374150 | Background | Butler SG, Stuart A, Markley L, Rees C. Penetration and aspiration in healthy older adults as assessed during endoscopic evaluation of swallowing. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):190-8. doi: 10.1177/000348940911800306. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Long-term Ventilated Subjects | Long-term (>10 days hours) ventilated subjects were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 long-term ventilated subjects were included (ventilated > 10 days). Subjects had a Richmond Agitation Sedation score of >0, had no delirium, had no abnormalities of the larynx or pharynx, and no history of chemotherapy or radiotherapy to the head/ neck, or of degenerative neurological disease.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Population | Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscle Strength | We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients. | Number | participants | Within 24 hours of fiberoptic endoscopic evaluation of swallow |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Long-term Ventilated Subjects | 30 consented long-term ventilated patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hooman Mirzakhani | Massachusetts General Hospital | 617-291-9779 | hmirzakhani@partners.org |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D012122 | Ventilators, Mechanical |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Whole Blood
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| Ventilator | Other | A mechanical ventilator is used to assist or replace spontaneous breathing. |
|
| 1745285 | Background | Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111. |
| 23584384 | Result | Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration | Number | participants | Within 3 month follow-up |
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| 0 |
| 30 |
| 0 |
| 30 |
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| D010038 | Otorhinolaryngologic Diseases |