COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements. The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.
COVID-19 patients with a severely symptomatic progression with development of an ARDS due to
SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization,
sedation and mechanical ventilation, leaving them at a very high risk for developing CIM. CIM
is associated with increased mortality and significant consequences for recovery and the
ability to return to normal daily life. Up to date, there are no studies investigating the
mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to
evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention
to the development of CIM and its underlying causes. To provide the possibility of early
diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane
alterations using MRVC measurements.
Objective:
The primary objective of this project is to prospectively evaluate the incidence and severity
of CIM in patients with ARDS due to SARS-CoV-2.
The secondary objectives of this project include:
1. To assess the quality of life of patients with and without CIM after ARDS due to
SARS-CoV-2.
2. To monitor changes in muscle excitability parameters in critically ill patients with
ARDS due to SARS-CoV-2 in relation to a later confirmed diagnosis of CIM according to
the current standards.
3. To explore underlying pathophysiological processes for CIM (mitochondrial dysfunction,
medication e.g. Neuromuscular blocking agents (NMBA), sedative drugs, and metabolic
(amino acids, inflammatory parameters)).
Method:
After enrolment in the study, patients will be examined for the first time within 24 hours
after admission to the ICU, and follow-up visits will be performed at day 2, 5 and 10 or upon
termination of therapy with NMBA, respectively. The endpoint will be at the clinical
follow-up appointment.
Procedure: Study Arm
First inpatient examination (within 24 hours after admission to ICU):
Clinical examination
Laboratory tests, Biobanking, Mitochondrial function testing
Neurophysiological examination (MVRC recording)
Follow-up inpatient examinations (day 2, 5 and 10 after admission):
Clinical examination
Laboratory tests, Biobanking, Mitochondrial functions testing
Neurophysiological examination (MVRC recording)
Day 10 only: Extended neurophysiological examination according to diagnostic criteria
Day 10 only: Grading of muscle strength (Medical Research Council (MRC) system)
Follow-up outpatient examination (after discharge from intensive care):
Clinical examination
Grading of muscle strength (MRC)
Modified Rankin Scale (mRS)
Barthel Scale
Questionnaires (Short Form (36) Health Survey, Essener Questionnaire for Coping with a Disease and Beck's Depression Inventory II)
Inclusion Criteria:
- Informed consent as documented by a surrogate assessment by an independent physician
- Adult ICU Patients with ARDS due to SARS-CoV-2 requiring mechanical ventilation
Exclusion Criteria:
- Age <18 years and > 80 years
- Pregnancy and breast feeding
- The presence of pre-existing:
- Known (at time of inclusion) Polyneuropathy,
- Known (at time of inclusion) Guillain-Barré syndrome,
- Known (at time of inclusion) Acute or chronic spinal cord lesion,
- Known (at time of inclusion) Myasthenia gravis, or
- Known (at time of inclusion) Myopathy
Inselspital Bern
Bern, Switzerland
Investigator: Werner Z'Graggen, MD
Contact: +41 31 632 79 09
werner.zgraggen@insel.ch
Investigator: Werner Z'Graggen, MD
Werner Z'Graggen, MD
+41316327909
werner.zgraggen@insel.ch
Nicoles Söll
+41316323164
nicole.soell@insel.ch
Werner Z'Graggen, MD, Principal Investigator
Universitätsklinik für Neurochirurgie und Neurologie