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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00893633
Date of registration: 05/05/2009
Prospective Registration: No
Primary sponsor: Clinical Institute of the Brain, Russia
Public title: Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients
Scientific title: Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit
Date of first enrolment: March 2004
Target sample size: 135
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00893633
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Russian Federation
Contacts
Name:     Andrey M Alasheev, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Clinical Institute of the Brain, Russia
Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Critical Illness
Muscle Weakness
Intervention(s)
Primary Outcome(s)
incidence of critical illness neuromuscular abnormalities (CINMAs) [Time Frame: within the first week of mechanical ventilation]
Secondary Outcome(s)
clinical and neurophysiological characteristics of CINMAs [Time Frame: within the first week of mechanical ventilation]
dynamics of the neurophysiological characteristics of CINMAs [Time Frame: during stay in ICU]
influence ?f phrenic nerve pathology on weaning from mechanical ventilation [Time Frame: during weaning period]
Secondary ID(s)
CINMAs-2004
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
City Clinical Hospital #40
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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