Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

This study has been completed.
Sponsor:
Collaborator:
City Clinical Hospital #40
Information provided by:
Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier:
NCT00893633
First received: May 5, 2009
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

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


Condition
Muscle Weakness
Critical Illness

Study Type: Observational
Study Design: 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

Further study details as provided by Clinical Institute of the Brain, Russia:

Primary Outcome Measures:
  • incidence of critical illness neuromuscular abnormalities (CINMAs) [ Time Frame: within the first week of mechanical ventilation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical and neurophysiological characteristics of CINMAs [ Time Frame: within the first week of mechanical ventilation ] [ Designated as safety issue: No ]
  • influence оf phrenic nerve pathology on weaning from mechanical ventilation [ Time Frame: during weaning period ] [ Designated as safety issue: No ]
  • dynamics of the neurophysiological characteristics of CINMAs [ Time Frame: during stay in ICU ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: March 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from neurosurgical ICU in city clinical hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893633

Locations
Russian Federation
Clinical Institute of the Brain
Ekaterinburg, Russian Federation, 620026
Sponsors and Collaborators
Clinical Institute of the Brain, Russia
City Clinical Hospital #40
Investigators
Principal Investigator: Andrey M Alasheev, MD, PhD Clinical Institute of the Brain, Russia
  More Information

No publications provided

Responsible Party: Andrey Alasheev, Clinical Institute of the Brain, Russia
ClinicalTrials.gov Identifier: NCT00893633     History of Changes
Other Study ID Numbers: CINMAs-2004
Study First Received: May 5, 2009
Last Updated: July 9, 2009
Health Authority: Russia: Ethics Committee

Keywords provided by Clinical Institute of the Brain, Russia:
neuromuscular diseases
critical illness
mechanical ventilation
phrenic nerve
nerve conduction studies

Additional relevant MeSH terms:
Critical Illness
Muscle Weakness
Paresis
Disease Attributes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014