Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Varese, Italien, 21100
- Azienda ospedaliera ospedale Circolo e Fondazione Macchi
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma
Tidsramme: Participants will be followed for 8 days
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Participants will be followed for 8 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The evaluation of consciousness.
Tidsramme: Participants will be followed for 8 days
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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.
Tidsramme: Participants will be followed for 8 days
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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
Tidsramme: Participants will be followed for 8 days
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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.
Tidsramme: Participants will be followed for 8 days
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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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Paolo MD Severgnini, Prof., Università degli Studi dell'Insubria, Varese, Italia
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 346
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