- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541602
Detection of Neuromuscular Complications in Critically Ill Patients (NMCiCIP)
Value of Neuromuscular Ultrasound and Blood Biomarkers for the Detection, Monitoring and Prognostication of Neuromuscular Complications in Critically Ill Patients: a Prospective Single-center Observational Study
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.
Study Overview
Status
Detailed 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 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Felix Klawitter, MD
- Phone Number: +493814946382
- Email: felix.klawitter@med.uni-rostock.de
Study Contact Backup
- Name: Johannes Ehler, MD
- Phone Number: +49381494146467
- Email: johannes.ehler@med.uni-rostock.de
Study Locations
-
-
Mecklenburg-Vorpommern
-
Rostock, Mecklenburg-Vorpommern, Germany, 18057
- Recruiting
- Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock
-
Contact:
- Felix Klawitter, MD
- Phone Number: +493814946382
- Email: felix.klawitter@med.uni-rostock.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients above 17 years of age
- Sequential organ failure assessment (SOFA) score ≥8 within the first two days after ICU admission
- invasive mechanical ventilation ≥48 hours
Exclusion Criteria:
- no written informed consent from patient or legal representative
- participation in another interventional study
- patient transfer from another hospital (>1 day hospital stay)
- preexisting swallowing disorder or disease of the larynx, pharynx or esophagus
- previous surgery of the larynx, pharynx, esophagus or maxillofacial surgery
- preexisting neuromuscular diseases
- preexisting central nervous system diseases (stroke, hemorrhage, tumor, traumatic brain injury, brain surgery, epilepsy, hydrocephalus)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Dysphagia-positive
|
Dysphagia-negative
|
Controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of sensomotory dysphagia in critically ill patients with and without intensive care unit-acquired weakness as well as controls
Time Frame: Day 90
|
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
Time Frame: Change from baseline ultrasound parameters at day 17
|
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
Time Frame: Change from baseline parameters at day 17
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life in patients with and without neuromuscular complications after hospital discharge
Time Frame: Day 90
|
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
Time Frame: 1 year
|
Cumulative days in hospital
|
1 year
|
Survival in critically ill patients with and without neuromuscular complications
Time Frame: Day 28
|
Survival after 28 days
|
Day 28
|
Survival in critically ill patients with and without neuromuscular complications
Time Frame: Day 90
|
Survival after 90 days
|
Day 90
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felix Klawitter, MD, University of Rostock
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCiCIP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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