Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

NCT05189561 | Completed

• 1 other identifier: NIMHANS/24thIEC(BS&NSDIV)
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; traumatic intracranial hematoma; extradural hematoma; subdural hematoma; cerebral contusion; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection rate of clinically significant intracranial hematoma

  Immediately after the test

Study Arms (1)

Cerebo®

EXPERIMENTAL

Participants undergoing scanning using NIRS device.

Other: near-infrared scanner

Interventions

near-infrared scanner 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

Also known as: Cerebo

Cerebo®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute traumatic brain injury patients reaching the hospital

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

NIMHANS

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hemorrhage, Traumatic; Hematoma, Epidural, Spinal; Hematoma, Subdural; Brain Contusion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Contusions; Wounds, Nonpenetrating

Study Officials

• Dhaval Shukla, MCh

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Neurosurgery

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 12, 2022
• Study Start: August 24, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

IN (1)