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Can quantitative evaluation of pupillary parameters in response to pain stimulation be used for prognostication of acute traumatic brain injury patients - A prospective study

Quantitative Pupillometric evaluation to noxious stimulation for prognostication of patients with acute traumatic brain injury - A prospective observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/063090
Enrollment
150
Registered
2024-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: S064- Epidural hemorrhage Health Condition 2: S063- Focal traumatic brain injury Health Condition 3: S020- Fracture of vault of skull Health Condition 4: S018- Open wound of other parts of head Health Condition 5: S068- Other specified intracranial injuries Health Condition 6: S066- Traumatic subarachnoid hemorrhage Health Condition 7: S065- Traumatic subdural hemorrhage

Interventions

Intervention1: NIL: NIL

Sponsors

NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients (18 - 75 years of age), with moderate to severe TBI admitted to Neuro ICU/ward within 48 hours of injury

Exclusion criteria

Exclusion criteria: 1. Absence of feasibility of performing Quantitative Pupillometry(QP) and ONSD assessment on the eye contralateral to the side with significant TBI (contralateral eye with pupillary disease or significant periorbital oedema where pupillary assessment is not possible) 2. Patients for whom consent is not available 3. Patients with significant co-morbidities/ extra cranial injuries where these are likely to affect survival

Design outcomes

Primary

MeasureTime frame
Association between the magnitude of change in QPi (amplitude of photomotor reflex) to noxious stimulation assessed in the contralateral pupil (opposite to injured side) using automated pupillometry and neurological outcome assessed using Glasgow Outcome Scale Extended (GOSE)Timepoint: 1. at discharge 2. at 3 months

Secondary

MeasureTime frame
1. Association between pupillary parameters other than QPi [pupillary diameter (PD), change in pupil diameter (measured as % variation), latency, constriction velocity (CV)] assessed using automated pupillometer during noxious stimulation, and neurological outcome assessed using m-GCS at hospital discharge, in-hospital mortality and GOSE after TBI in ICU and ward patients 2. Association between anisocoria and neurological outcome assessed using m-GCS at hospital discharge, in-hospital mortality and GOSETimepoint: 1. At 3 months 2. At 6 months;3.To determine the correlation between nurse assessed pupillary diameter before light reflex and baseline pupil diameter assessed with automated pupillometer in ICU 4. To assess the effect of opioid (if administered as part of sedoanalgesia) on QPi in ICU Timepoint: At initial assessment after admission to ICU within 48 hours of injury;5.To evaluate the correlation between BPS and pupillary parameters after TBI during noxious stimulations such as tracheal suctioning and supraorbital pressure in ICU 6.To determine correlation of ONSD with QPi response to noxious stimuli in ICU 7.To determine correlation of change in depth of consciousness assessed on forehead contralateral to the injured side/ less injured side assessed using Bispectral Index (BIS) and hemodynamic parameters – heart rate and mean arterial pressure with the change in QPi in response to noxious stimuli in ICU Timepoint: At 12 hour intervals for 3 days or till discharge after admission to ICU/ward post surgery whichever is earlier

Countries

India

Contacts

Public ContactDeeparaj L

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Bangalore

itz.sonia77@gmail.com9008721921

Outcome results

None listed

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