Clinical trial NCT00893633: Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients
Official title: Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Weakness
Critical Illness
Keywords: neuromuscular diseases
critical illness
mechanical ventilation
phrenic nerve
nerve conduction studies
Lead sponsor: Clinical Institute of the Brain, Russia
Sponsor class: OTHER
Collaborators: name: City Hospital No 40, Saint Petersburg, Russia
First posted: 2009-05-06
Enrollment: 135
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from neurosurgical ICU in city clinical hospital

Brief summary: The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.

Detailed description: Since 1984, the problem of critical illness neuromuscular abnormalities (CINMAs) has attracted considerable interest. According to these studies, CINMAs include the muscular weakness that accompanies critical illness resulting from polyneuropathy and/or myopathy and can be seen in 25-85% of cases of critically ill patients. Clinically, CINMAs present as symmetric flaccid tetraparesis and difficulty weaning off mechanical lung ventilation. However, these data are derived from treating non-specialized intensive care unit (ICU) patients. In this research, we wished to investigate CINMAs in neurocritical care patients. From day one of the patients' participation in the research and until a discharge from the ICU (or death), daily neurological surveys and weekly nerve conduction studies were performed. Based on the results of each nerve conduction study, an index of neuromuscular damage was noted to evaluate the severity of the CINMAs. Needle electromyography and muscle biopsy were not used

Eligibility criteria: Inclusion Criteria:

* Age: 16 years and older
* Acute primary cerebral pathology
* Mechanical ventilation
* Signs of systemic inflammatory response
* Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history

Exclusion Criteria:

* Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness
* Inability to perform high-grade nerve conduction studies

Primary outcomes:
measure: incidence of critical illness neuromuscular abnormalities (CINMAs)
timeFrame: within the first week of mechanical ventilation
Secondary outcomes:
measure: clinical and neurophysiological characteristics of CINMAs
timeFrame: within the first week of mechanical ventilation
measure: influence оf phrenic nerve pathology on weaning from mechanical ventilation
timeFrame: during weaning period
measure: dynamics of the neurophysiological characteristics of CINMAs
timeFrame: during stay in ICU
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Clinical Institute of the Brain
Study officials:
affiliation: Clinical Institute of the Brain, Russia
name: Andrey M Alasheev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: