Clinical trial NCT05189561: Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection
Official title: Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
traumatic intracranial hematoma
extradural hematoma
subdural hematoma
cerebral contusion
near-infrared spectroscopy
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria:

* Major scalp laceration or active bleeding.
* Significant extracranial hematoma.

Primary outcomes:
measure: Detection rate of intracranial hematoma
timeFrame: Immediately after the test
Secondary outcomes:
measure: Detection rate of clinically significant intracranial hematoma
timeFrame: Immediately after the test
Other outcomes:
Locations:
city: Bangalore
country: India
facility: NIMHANS
state: KA
Study officials:
affiliation: National Institute of Mental Health and Neuro Sciences, India
name: Dhaval Shukla, MCh
role: PRINCIPAL_INVESTIGATOR
References: