Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
- 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.
- nd endpoint: relate data obtained with clinical evaluation of the patient (cerebral physiology and outcome)
- 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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Varese, Italien, 21100
- Azienda ospedaliera ospedale Circolo e Fondazione Macchi
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma
Tidsram: Participants will be followed for 8 days
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Participants will be followed for 8 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The evaluation of consciousness.
Tidsram: Participants will be followed for 8 days
|
During the observation are evaluated: • Glasgow Coma Scale (GCS). |
Participants will be followed for 8 days
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The evaluation of clinical conditions.
Tidsram: 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). |
Participants will be followed for 8 days
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The evaluation of brain pressures
Tidsram: Participants will be followed for 8 days
|
During the observation are evaluating: • Intracranial Cerebral Pressure (ICP) if monitored and perfusional cerebral pressure(PCP); |
Participants will be followed for 8 days
|
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The evaluation of cardiac monitoring.
Tidsram: Participants will be followed for 8 days
|
During the observation are evaluating: • Mean arterial pressure (MAP), cardiac frequency (FC), body temperature, water balance, diuresis; |
Participants will be followed for 8 days
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Paolo MD Severgnini, Prof., Università degli Studi dell'Insubria, Varese, Italia
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 346
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