An observational study in Brain Death, Brain Injuries and Brain Edema, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Aristotle University Of Thessaloniki · Observational
The study will examine the resting energy need (REE) in patients suffering from brain damage. For the measurement of REE will be used a metabolic computer (which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.
This is a retrospective observational study concerning patients suffering from brain damage.
All the patients suffering from brain damage are monitored in order to examine their resting energy needs (REE). For the measurement of REE the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA) is used.
The main purpose of this study is to reveal the (REE) changing in patients with brain death semiology and examine if the REE changes could be related to the outcome of a patient with intracranial pathology. Moreover the study will examine if the changes in REE measurement are related to changes in flow velocities in the midbrain.
Any measurement shall be preceded by calibration of the metabolic computer pneumotachograph with a 3-liter syringe with an acceptable error of less than 9 ml / lit. The metabolic unit is calibrated for VO2 measurements with two calibration cylinders containing 21% and 12% O2 and for VCO2 measurements with calibration gases containing 5% and 0% CO2 respectively.
The measurement of flow velocities in the middle cerebral artery will be done with the transcranial Doppler using a low frequency (2 MHz) ultrasound head After their final diagnosis (brain death or not) the patients' characteristics will be compared according to the categorization as "brain dead" or not.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 66 is below the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
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Adult patients, aged 18-90 years old, entering the ICU, having a GCS \<=8 before any intervention, having signs of intracranial damage after a traumatic brain injury or a cardiac arrest succesfull rescucitation or a brain hemorrhage due to aneurysm.
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Exclusion Criteria:
ICU patients with brain damage (due to cardiac arrest, intracranial hemorrhage or traumatic brain injury). and GCS upon entry \<=8. All patients will be examined with a transcranial doppler (TCD) and a metabolic computer (for the measurements of REE) After the final diagnosis the patients' characteristics will be compared according to if they were brain dead or not
Diagnostic Test: REE - Resting Energy Expenditure · Diagnostic Test: Transcranial Doppler
REEs represent 60-70% of the needs for a sedentary person and 50% of physically active people. For the measurement of REE will be used the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA), which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ. All patients in the study will be monitored with the metabolic computer. Their measurements will be recorded every day during their stay in the ICU.
The measurement of flow velocities in the middle cerebral artery will be done with the transcranial Doppler using a low frequency (2 MHz) ultrasound head. All patients entering the study will be examined with the TCD every day during their stay in the ICU.
REE changes
Changes in REE in patients with brain damage
Time frame: Day 0 (upon entry to ICU) up to 30 days
MCA changes
Changes in flow rates in Median Cerebral Artery (MCA) in patients with brain damage
Time frame: Day 0 (upon entry to ICU) up to 30 days
REE and MCA correlation
Correlate the REE changes with those in flow rates in MCA
Time frame: Day 0 (upon entry to ICU) up to 30 days
Prognostic value of REE
Compare the values of REE upon entry in the ICU in patients with final diagnosis as brain dead or not
Time frame: Day 0 (upon entry to ICU) up to 30 days
Plan to share: Undecided
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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