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Clinical Trials/CTRI/2024/03/063434
CTRI/2024/03/063434Not yet recruitingNot Applicable

NIRS in traumatic intracranial hematoma detection in traumatic head injury

Dr Dhaval Shukla1 site in 1 country91 target enrollmentStarted: March 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
91
Locations
1
Primary Endpoint
Sensitivity, Specificity and Accuracy of NIRS for detecting traumatic intracranial hematoma.

Study Overview

Brief Summary

Early detection and timely treatment of intracranial injuries in children are crucial for improving outcomes and reducing long-term impacts of TBI. By potentially shortening the time to diagnosis and treatment, CEREBO may offer significant benefits in the management of pediatric TBI, thus contributing to better healthcare outcomes in this vulnerable population. This clinical trial aims to evaluate the performance of CEREBO, an innovative intracranial injury detector, in identifying traumatic intracranial injuries within the pediatric population aged 0 to 18 years. The study’s primary objective is to assess CEREBO’s efficacy and accuracy in early detection of intracranial injuries resulting from trauma. The study will involve pediatric patients who present with signs or risks of traumatic brain injury (TBI). CEREBO will be used to assess these patients, and its findings will be compared with the results of head CT scans, the current standard in intracranial injury diagnosis. The primary outcome of the study is to facilitate early detection of intracranial injuries Thus the study will provide critical data on the effectiveness of CEREBO in a pediatric setting and its potential role in transforming the current approach to TBI management in children. The study will also assess the efficacy of the NIRS device in continuous monitoring of TBI patients under conservative treatment. It will evaluate whether there exists a significant correlation between the NIRS data  and the depth and volume of hematoma within the same subject.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Year(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with Acute head injury and are referred for a head CT scan.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sensitivity, Specificity and Accuracy of NIRS for detecting traumatic intracranial hematoma.

Time Frame: 3 years

Secondary Outcomes

  • To evaluate the NIRS based device for continuous monitoring of TBI patients under conservative treatment.(3 years)
  • Usability parameters including but not limited to ease of use, scan time, etc.(3 years)

Investigators

Sponsor
Dr Dhaval Shukla
Sponsor Class
Other [self]

Study Sites (1)

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