Detection of Neuromuscular Complications in Critically Ill Patients

NCT ID: NCT04541602

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-12-08

Brief Summary

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.

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

Conditions

Critical Illness; Dysphagia; Intensive Care Unit Acquired Weakness; Neuromuscular Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dysphagia-positive

• critically ill patients more than 17 years of age
• matching study inclusion criteria
• confirmed newly acquired swallowing dysfunction using FEES at study day 10 or later
• ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48)

No interventions assigned to this group

Dysphagia-negative

• critically ill patients more than 17 years of age
• matching study inclusion criteria
• newly acquired swallowing dysfunction ruled out using FEES at study day 10 or later
• ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48)

No interventions assigned to this group

Controls

• healthy volunteers without any neuromuscular disease
• swallowing dysfunction ruled out using FEES

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Dr. Johannes Ehler, MD

PD Dr. med. Johannes Ehler, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felix Klawitter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Johannes Ehler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Countries

Germany

Other Identifiers

NMCiCIP

Identifier Type: -

Identifier Source: org_study_id