Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Critical Illness
  • Dysphagia
  • Intensive Care Unit Acquired Weakness
  • Neuromuscular Diseases
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 neurolo...

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: acquired dysphagia due to critical illness (not caused by central nervous system damage) is more likely in patients with ICU-AW the outcome in patients with a combination of ICU-AW and dysphagia is worse compared to patients with only one of these entities NMUS is able to detect and monitor dysphagia and ICU-AW in critically ill patients who are at risk of neuromuscular dysfunction specific blood biomarker levels correlate with the severity of neuromuscular impairment and are of value to identify patients with ICU-AW and acquired dysphagia

Tracking Information

NCT #
NCT04541602
Collaborators
Not Provided
Investigators
Principal Investigator: Felix Klawitter, MD University of Rostock Principal Investigator: Johannes Ehler, MD University of Rostock