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PI and the majority of the study team left institution.
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Dysphagia and the intensive care unit-acquired weakness (ICU-AW) are common and outcome-relevant neuromuscular complications in critically ill patients, especially after prolonged mechanical ventilation, sepsis and multi-organ failure. However, the impact of these two complications on the clinical course of critically ill patients needs further investigation.
Furthermore, the standard diagnostic procedure to detect and grade the acquired dysphagia using the fiberoptic endoscopic evaluation of swallowing (FEES) and the Medical Research Council sum score (MRC-ss) to detect ICU-AW are time-consuming and strongly dependent on patient compliance. An early and easy-to-use detection of these neuromuscular complications is currently difficult to be achieved in this patient population.
Neuromuscular ultrasound (NMUS) and the measurement of neuromuscular damage blood biomarkers became increasingly interesting for clinical researchers in the recent years due to their broad availability and their simple and non-invasive application. However, the value of these new diagnostic tests to evaluate dysphagia and ICU-AW needs to be verified.
In this single-center observational study the investigators aim to evaluate neuromuscular ultrasound and blood biomarkers of neuromuscular damage as innovative diagnostic features for the detection, monitoring and prognostication of dysphagia and ICU-AW in critically ill patients. A detailed neurological examination, NMUS as well as blood biomarker measurements (e.g. Myl3, TNNI1, FABP-3) will be longitudinally performed at study day 1 (day of study inclusion), day 3, day 10 and day 17 after study inclusion. The neurological examination comprises the use of validated scales (GCS, RASS, mRS) and scores (MRC-ss) to assess consciousness, neurological disability and muscle strength as well as the the examination of the reflex status. Using a standardized in-house NMUS protocol the facial (masseter muscle), submental (digastricus muscle, mylohyoid muscle), cervical (sternocleidomastoid muscle) and extremity muscles (biceps brachii, brachiradialis, quadriceps femoris, tibialis anterior) as well as the vagus nerve will be assessed repeatedly. Additionally, a FEES as the current gold standard diagnostic for dysphagia will be performed at study day 10 or as soon as possible (depending on the ability of the patient to cooperate with the examiner) after study day 10 to detect and grade the dysphagia.
All study participants will be reevaluated at day 90 after study inclusion with regard to functional disability and survival.
Furthermore, healthy volunteers will be recruited and assessed in the same way as patients including a clinical examination, NMUS, laboratory testing and FEES.
The investigators hypothezise that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysphagia-positive |
| ||
| Dysphagia-negative |
| ||
| Controls |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sensomotory dysphagia in critically ill patients with and without intensive care unit-acquired weakness as well as controls | Assessment of dysphagia and ICU-AW using validated diagnostics (FEES, NMUS) and scores (MRC-ss) | Day 90 |
| Changes in ultrasonographic parameters between patients with and without newly acquired sensomotory dysphagia as well as controls | NMUS protocol performed at study days 1, 3, 10 and 17 | Change from baseline ultrasound parameters at day 17 |
| Change in neuromuscular damage blood biomarker levels in critically ill patients with and without newly acquired sensomotory dysphagia as well as controls | Specific blood biomarker levels (e.g. TNNI1, FABP-3) measured at study days 1, 3, 10 and 17 | Change from baseline parameters at day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life in patients with and without neuromuscular complications after hospital discharge | Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)] | Day 90 |
| Length of hospital stay comparing critically ill patients with and without neuromuscular complications |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted to the intensive care units of the study center will be screened for study eligibility according to the inclusion and exclusion criteria. Additionally, healthy volunteers will be recruited to participate as controls.
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| Name | Affiliation | Role |
|---|---|---|
| Felix Klawitter, MD | University of Rostock | Principal Investigator |
| Johannes Ehler, MD | University of Rostock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003680 | Deglutition Disorders |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
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Blood samples
Cumulative days in hospital |
| 1 year |
| Survival in critically ill patients with and without neuromuscular complications | Survival after 28 days | Day 28 |
| Survival in critically ill patients with and without neuromuscular complications | Survival after 90 days | Day 90 |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |