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Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893633
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : July 10, 2009
City Hospital No 40, Saint Petersburg, Russia
Information provided by:
Clinical Institute of the Brain, Russia

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

Condition or disease
Muscle Weakness Critical Illness

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

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit
Study Start Date : March 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. incidence of critical illness neuromuscular abnormalities (CINMAs) [ Time Frame: within the first week of mechanical ventilation ]

Secondary Outcome Measures :
  1. clinical and neurophysiological characteristics of CINMAs [ Time Frame: within the first week of mechanical ventilation ]
  2. influence оf phrenic nerve pathology on weaning from mechanical ventilation [ Time Frame: during weaning period ]
  3. dynamics of the neurophysiological characteristics of CINMAs [ Time Frame: during stay in ICU ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from neurosurgical ICU in city clinical hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00893633

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Russian Federation
Clinical Institute of the Brain
Ekaterinburg, Russian Federation, 620026
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
City Hospital No 40, Saint Petersburg, Russia
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Principal Investigator: Andrey M Alasheev, MD, PhD Clinical Institute of the Brain, Russia

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Responsible Party: Andrey Alasheev, Clinical Institute of the Brain, Russia Identifier: NCT00893633    
Other Study ID Numbers: CINMAs-2004
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009
Keywords provided by Clinical Institute of the Brain, Russia:
neuromuscular diseases
critical illness
mechanical ventilation
phrenic nerve
nerve conduction studies
Additional relevant MeSH terms:
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Muscle Weakness
Critical Illness
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms