Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

Critical Illness Clinical Trial

Official title:

Prospective Case-Only Study of Neuromuscular Pathology in Patients on Mechanical Ventilation in the Neurosurgical Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893633
• Other study ID #: CINMAs-2004
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: July 9, 2009
• Start date: March 2004
• Est. completion date: January 2007

Study information

• Verified date: July 2009
• Source: Clinical Institute of the Brain, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness
• Paresis

Locations

Country	Name	City	State
Russian Federation	Clinical Institute of the Brain	Ekaterinburg

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Institute of the Brain, Russia	City Hospital No 40, Saint Petersburg, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of critical illness neuromuscular abnormalities (CINMAs)		within the first week of mechanical ventilation	No
Secondary	clinical and neurophysiological characteristics of CINMAs		within the first week of mechanical ventilation	No
Secondary	influence ?f phrenic nerve pathology on weaning from mechanical ventilation		during weaning period	No
Secondary	dynamics of the neurophysiological characteristics of CINMAs		during stay in ICU	No