Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01990963

Enrollment

Registered

2013-11-25

Start date

2010-01-31

Completion date

2017-05-31

Last updated

2017-05-25

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

Conditions

Severe Brain Trauma

Keywords

Brain trauma;, MALUNA;, densitometric data, CT

Brief summary

Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of brain tissue after patients with severe brain trauma

Detailed description

Quantitative analysis of brain and structures in it, in terms of volume, weight and density, in patients with severe brain trauma, using MALUNA dedicated software to process DICOM images. 1. st endpoint: compare these data with those obtained by CT scans analysis of patients that recur to this kind of diagnostic investigation for non-traumatic events and with negative diagnostic related to cerebral pathological implication. 2. nd endpoint: relate data obtained with clinical evaluation of the patient (cerebral physiology and outcome) 3. rd endpoint: evaluate differences in terms of volume, weight and density of brain and its structures, between patients with diffuse cerebral injury and those with localized lesions.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female, any ethnic group * Patient with severe brain trauma (GCS \< 8) * Need of mechanical ventilation * Clinical need of urgent CT study of brain. * Need of clinical control of CT study of brain within first 72 hours from event * Informed consent obtained from solicitor, due to the fact that patient is

Exclusion criteria

* Age minor than 18 yrs old at hospitalization day * Cardiac arrest pre-hospital or in-hospital and post-anoxic coma * Non traumatic coma * Exaggerated ingestion of depressors of central nervous system * Documented abuse of narcotic drugs; * Documented abuse of alcohol

Design outcomes

Primary

Measure	Time frame
The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma	Participants will be followed for 8 days

Secondary

Measure	Time frame	Description
The evaluation of consciousness.	Participants will be followed for 8 days	During the observation are evaluated: • Glasgow Coma Scale (GCS).
The evaluation of clinical conditions.	Participants will be followed for 8 days	During the observation are evaluated multiparametric arterial and venous gas analysis : partial pressure of oxygen in arterial blood(PaO2); partial pressure of carbon dioxide in the arterial blood (PaCO2); cerebral venous oxygen saturation (SjO2); arterial oxygen saturation (SaO2); measure of the acidity or basicity of an aqueous solution (pH); base excess (B.E.); bicarbonate ion (HCO3-); sodium ion (Na+); potassium ion (K+); glycemia; blood concentration of hemoglobin(Hb); hematocrit (Ht).
The evaluation of brain pressures	Participants will be followed for 8 days	During the observation are evaluating: • Intracranial Cerebral Pressure (ICP) if monitored and perfusional cerebral pressure(PCP);
The evaluation of cardiac monitoring.	Participants will be followed for 8 days	During the observation are evaluating: • Mean arterial pressure (MAP), cardiac frequency (FC), body temperature, water balance, diuresis;

Countries

Italy

Outcome results