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Brain Death progression assessment following severe brain damage using multimodal monitoring with Near Infrared spectroscopy, Automated Pupillometry and Optic nerve sheath diameter

Multimodal Monitoring with Near-Infrared Spectroscopy, Automated Pupillometry and Optic Nerve Sheath Diameter for Assessment of Brain Death Progression following Severe Brain Damage

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098504
Enrollment
20
Registered
2025-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between the ages of 15 and 75 admitted to the neuro-ICU with severe brain damage of known etiology [aneurysmal subarachnoid hemorrhage (a SAH), traumatic brain injury (TBI), brain tumor, intracerebral hemorrhage (ICH), acute ischemic stroke] and deeply comatose (GCS- 3)

Exclusion criteria

Exclusion criteria: 1.Refusal of consent by a relative. 2.CNS infections as the cause of coma/ Severe sepsis. 3.Severe facial trauma, including forehead scalp hematomas, cranial metal implants. 4.History of raised intra-ocular pressure and eye trauma precluding measurement of QPi and ONSD. 5.Un-evacuated frontal subdural hematoma (SDH). 6.Polytrauma with lung injury and prior history of respiratory disease impeding ventilation and oxygenation. 7.Prior history of cardiovascular disease.

Design outcomes

Primary

MeasureTime frame
Serial measurements of rSO2, QPi, and ONSD from a state of deep coma till brain death confirmation.Timepoint: Once the patient with GCS of 3 develops FOUR score of 0, a state of IBD will be considered. Neurological and hemodynamic monitoring, NIRS,QPi and ONSD values will be documented every 6th hour until apnea test establishes a confirmatory diagnosis of brain death or neurological recovery occurs. Time to development of IBD and brain death confirmation will be noted.

Secondary

MeasureTime frame
1.Patient outcome (improved GCS/FOUR Scores or positive apnea test or cardiac death) 2.Time to brain death diagnosis. 3.Time to cardiac death after diagnosis of brain death Timepoint: Once the patient with GCS of 3 develops FOUR score of 0, a state of IBD will be considered. Neurological & hemodynamic monitoring, NIRS, QPi, & ONSD values will be documented every 6th hour until the apnea test establishes a confirmatory diagnosis of brain death or neurological recovery occurs. Time to development of IBD & brain death confirmation will be noted

Countries

India

Contacts

Public ContactDr Girija Parsad Rath

AIIMS New Delhi

girijarath.aiims@gmail.com9810602272

Outcome results

None listed

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