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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.
 
ClinicalTrials.gov Identifier: NCT00893633
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : July 10, 2009
Sponsor:
Collaborator:
City Hospital No 40, Saint Petersburg, Russia
Information provided by:
Clinical Institute of the Brain, Russia

Tracking Information
First Submitted Date May 5, 2009
First Posted Date May 6, 2009
Last Update Posted Date July 10, 2009
Study Start Date March 2004
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2009)
incidence of critical illness neuromuscular abnormalities (CINMAs) [ Time Frame: within the first week of mechanical ventilation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2009)
  • clinical and neurophysiological characteristics of CINMAs [ Time Frame: within the first week of mechanical ventilation ]
  • influence оf phrenic nerve pathology on weaning from mechanical ventilation [ Time Frame: during weaning period ]
  • dynamics of the neurophysiological characteristics of CINMAs [ Time Frame: during stay in ICU ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients from neurosurgical ICU in city clinical hospital
Condition
  • Muscle Weakness
  • Critical Illness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2009)
135
Original Actual Enrollment Same as current
Actual Study Completion Date January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT00893633
Other Study ID Numbers CINMAs-2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrey Alasheev, Clinical Institute of the Brain, Russia
Study Sponsor Clinical Institute of the Brain, Russia
Collaborators City Hospital No 40, Saint Petersburg, Russia
Investigators
Principal Investigator: Andrey M Alasheev, MD, PhD Clinical Institute of the Brain, Russia
PRS Account Clinical Institute of the Brain, Russia
Verification Date July 2009