Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Other: near-infrared scanner

• Registration Number: NCT05189561
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

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.

Study Timeline

• Study Start: 2021-08-24
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2022-01-08
• Study First Posted: 2022-01-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebo®	near-infrared scanner	Participants undergoing scanning using NIRS device.

Primary Outcome Measures

Name	Time	Method
Detection rate of intracranial hematoma	Immediately after the test	To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.

Secondary Outcome Measures

Name	Time	Method
Detection rate of clinically significant intracranial hematoma	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.

Trial Locations

Locations (1)

NIMHANS; 🇮🇳 Bangalore, KA, India