FindTrial
Sign In

To assess the effectiveness of a Near Infrared Spectroscopy based Device - CEREBO to detect intracranial hematoma in traumatic brain injury in children less than 18 years of age

NIRS in traumatic intracranial hematoma detection in traumatic head injury - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/063434
Enrollment
91
Registered
2024-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S06- Intracranial injury Health Condition 2: S000- Superficial injury of scalp

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Dhaval Shukla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Acute head injury and are referred for a head CT scan.

Exclusion criteria

Exclusion criteria: Major scalp laceration or active bleeding. Significant extracranial hematoma.

Design outcomes

Primary

MeasureTime frame
Sensitivity, Specificity and Accuracy of NIRS for detecting traumatic intracranial hematoma. Timepoint: 3 years—

Secondary

MeasureTime frame
To evaluate the NIRS based device for continuous monitoring of TBI patients under conservative treatment.Timepoint: 3 years;Usability parameters including but not limited to ease of use, scan time, etc.Timepoint: 3 years—

Countries

India

Contacts

Public ContactDr Dhaval Shukla

National Institute of Mental Health and Neuro Sciences

neurodhaval@rediffmail.com9898073843

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026