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COMPLETED
NCT07853963
NA

Invasive Versus Non-Invasive Intracranial Pressure-Guided Management in Neurosurgical Patients

Sponsor: Kathmandu Medical College and Teaching Hospital

View on ClinicalTrials.gov

Summary

Raised intracranial pressure (pressure inside the skull) is a serious complication for patients with brain injuries, strokes, or tumors. Managing this pressure is critical to prevent further brain damage. This study compares two different methods of monitoring and managing brain pressure to see which leads to better patient recovery. Participants in this study are adult patients admitted to the neurosurgery department who require monitoring for high brain pressure. The study involves two groups: 1. Invasive Monitoring Group: Patients receive a standard treatment where a small tube (external ventricular drain) is surgically placed into the fluid spaces of the brain to directly measure pressure and drain fluid if needed. 2. Non-Invasive Monitoring Group: Patients are monitored using an ultrasound on the outside of the eye to measure the swelling of the optic nerve, which estimates brain pressure without requiring surgery. The main goal of this study is to compare how patients in each group recover by tracking their level of consciousness (using the Glasgow Coma Scale) over their first five days of admission. The study will also evaluate patient recovery at the time of hospital discharge, the length of the hospital stay, and any medical complications.

Official title: Invasive Versus Non-Invasive Intracranial Pressure Guided Management and Neurological Outcomes in Neurosurgical Patients: A Prospective Comparative Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-01-01

Completion Date

2025-12-15

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

PROCEDURE

External Ventricular Drain (EVD) Placement and ICP Monitoring

Following standard neurosurgical aseptic protocol, an external ventricular drain (EVD) or cisternal drain is placed and connected to a pressure transducer and drainage chamber. Intracranial pressure (ICP) is measured continuously and recorded at hourly intervals. This intervention also includes therapeutic cerebrospinal fluid (CSF) drainage as a tier-1 active ICP-control measure.

DIAGNOSTIC_TEST

Optic Nerve Sheath Diameter (ONSD) Ultrasonography

Bedside ultrasonographic measurement of the optic nerve sheath diameter (ONSD) is performed using a high-frequency (7.5 MHz) linear probe. Measurements are conducted 3 mm behind the retina from outer edge to outer edge of the sheath. Readings are obtained hourly for the first 24 hours, four-hourly up to 72 hours, and twice daily from day 3 to day 5, with additional measurements taken upon sudden neurological deterioration.

Locations (1)

Kathmandu Medical College

Kathmandu, Bagmati, Nepal