Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

NCT ID: NCT05189561

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-24
• Study Completion Date: 2021-10-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cerebo®

Participants undergoing scanning using NIRS device.

Group Type: EXPERIMENTAL

near-infrared scanner

Intervention Type: OTHER

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

Interventions

near-infrared scanner

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

Intervention Type: OTHER

Other Intervention Names

Cerebo

Eligibility Criteria

Inclusion Criteria

• Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Dhaval Shukla

Prof. of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhaval Shukla, MCh

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuro Sciences, India

Locations

NIMHANS

Bangalore, Karnataka, India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NIMHANS/24thIEC(BS&NSDIV)

Identifier Type: -

Identifier Source: org_study_id