- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05189561
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue, it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral white matter. However, red blood cells, which represent roughly have a low scattering effect and high absorption. Utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. The 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low power non risky device that can screen the patient's head multiple times without causing any side effect. The built in safety features in Cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. The average power and total power dissipation is very low. The system poses no risk to the patients who will be included in the study.
So far the overall results of detection rate of hematoma using NIRS device are contradictory. It is not the replacement of a CT scan but can help in triage. In the present research the investigators plan to do a large scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan findings.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
KA
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Bangalore, KA, Indien, 560029
- NIMHANS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Acute traumatic brain injury patients reaching the hospital
Exclusion Criteria:
- Major scalp laceration or active bleeding.
- Significant extracranial hematoma.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Cerebo®
Participants undergoing scanning using NIRS device.
|
Tests to be administered: Near Infra-Red Scanning of the head at the bedside. Time taken for testing: Two minutes Biological samples collected: None Frequency of testing/collection: Once Risks for the participants while being tested: None
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Detection rate of intracranial hematoma
Tidsramme: Immediately after the test
|
To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.
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Immediately after the test
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Detection rate of clinically significant intracranial hematoma
Tidsramme: Immediately after the test
|
To evaluate detection rate of clinically significant intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India), which requires admission or surgical intervention.
|
Immediately after the test
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dhaval Shukla, MCh, National Institute of Mental Health and Neuro Sciences, India
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- NIMHANS/24thIEC(BS&NSDIV)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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