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Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00918970
Acronym
MEANS
Enrollment
30
Registered
2009-06-11
Start date
2008-08-31
Completion date
2009-06-30
Last updated
2009-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hematoma, Traumatic, Intracerebral Hemorrhage, Traumatic, Traumatic Brain Hemorrhage, Traumatic Brain Injury

Keywords

autonomous nervous system, brain death, organs transplantation

Brief summary

Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit. The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors. Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

Detailed description

Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death. Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.

Interventions

None listed

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* severe cerebral lesions * admitted in intensive care units

Exclusion criteria

* neoplastic pathology * prior myocardiac infarction * hearth failure * atrial fibrillation * insulin-treated diabetes mellitus * cardiac pacemaker

Design outcomes

Primary

MeasureTime frame
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiographyAt confirmation of the brain death

Secondary

MeasureTime frame
the number of patients and the number of organs removedAt the end of the study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026