Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

July 9, 2009 updated by: Clinical Institute of the Brain, Russia

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620026
        • Clinical Institute of the Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from neurosurgical ICU in city clinical hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of critical illness neuromuscular abnormalities (CINMAs)
Time Frame: within the first week of mechanical ventilation
within the first week of mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical and neurophysiological characteristics of CINMAs
Time Frame: within the first week of mechanical ventilation
within the first week of mechanical ventilation
influence оf phrenic nerve pathology on weaning from mechanical ventilation
Time Frame: during weaning period
during weaning period
dynamics of the neurophysiological characteristics of CINMAs
Time Frame: during stay in ICU
during stay in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINMAs-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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