Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

Traumatic Brain Injury Clinical Trial

Official title:

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189561
• Other study ID #: NIMHANS/24thIEC(BS&NSDIV)
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria:

• Major scalp laceration or active bleeding.

• Significant extracranial hematoma.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hematoma
• Traumatic Brain Injury

Intervention

Other:
• 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

Locations

Country	Name	City	State
India	NIMHANS	Bangalore	KA

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of intracranial hematoma	To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.	Immediately after the test
Secondary	Detection rate of clinically significant intracranial hematoma	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