Detection of Neuromuscular Complications in Critically Ill Patients

NCT04541602 | Terminated

• 1 other identifier: NMCiCIP
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Quality of life in patients with and without neuromuscular complications after hospital discharge

  Day 90

• Length of hospital stay comparing critically ill patients with and without neuromuscular complications

  1 year

• Survival in critically ill patients with and without neuromuscular complications

  Day 28

• Survival in critically ill patients with and without neuromuscular complications

  Day 90

Study Arms (3)

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)

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)

Controls

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

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

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Critical Illness; Deglutition Disorders; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Study Officials

• Felix Klawitter, MD

  University of Rostock

  PRINCIPAL INVESTIGATOR

• Johannes Ehler, MD

  University of Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Johannes Ehler, MD

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: September 1, 2020
• Primary Completion: December 8, 2024
• Study Completion: December 8, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)