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

NCT07853963 | Completed

• 1 other identifier: 101123/22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Intracranial Hypertension; Traumatic Brain Injury; Subarachnoid Haemorrhage (SAH); Intracerebral Haemorrhage; Hydrocephalus

Keywords

Intracranial pressure; Optic nerve sheath diameter; Glasgow Coma Scale; External ventricular drain; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Trajectory of Neurological Recovery Assessed by Glasgow Coma Scale (GCS) Score

  The GCS assesses a patient's level of consciousness on a scale from 3 (deep coma) to 15 (fully awake). Higher scores indicate better neurological function. Measurements were taken twice daily to compare the rate of neurological improvement between the invasive and non-invasive monitoring groups.

  Twice daily (9 AM and 9 PM) for 5 consecutive days following admission

Secondary Outcomes (4)

• Functional Outcome Assessed by Glasgow Outcome Scale (GOS)

  At the time of hospital discharge (an average of 11 to 15 days)

• Functional Outcome Assessed by Modified Rankin Scale (mRS)

  At the time of hospital discharge (an average of 11 to 15 days)

• Length of Hospital Stay

  From hospital admission to hospital discharge (average of 11 to 15 days)

• Incidence of Mortality and Medical/Procedural Complications

  From hospital admission to hospital discharge (average of 11 to 15 days)

Study Arms (2)

Invasive ICP Monitoring Group

ACTIVE COMPARATOR

Patients managed with invasive intracranial pressure (ICP) monitoring. Following standard neurosurgical aseptic protocol, an external ventricular drain (EVD) or cisternal drain is placed and connected to a pressure transducer to allow continuous ICP measurement and therapeutic cerebrospinal fluid (CSF) drainage.

Procedure: External Ventricular Drain (EVD) Placement and ICP Monitoring

Non-Invasive ONSD Monitoring Group

EXPERIMENTAL

Patients managed with non-invasive ICP monitoring using bedside ultrasonographic measurement of the optic nerve sheath diameter (ONSD) using a high-frequency (7.5 MHz) linear probe. Measurements are taken at scheduled intervals or upon neurological deterioration to guide clinical decisions and tiered medical management for raised ICP.

Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) Ultrasonography

Interventions

External Ventricular Drain (EVD) Placement and ICP Monitoring PROCEDURE

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.

Also known as: Invasive ICP Monitoring, Therapeutic CSF Drainage

Invasive ICP Monitoring Group

Optic Nerve Sheath Diameter (ONSD) Ultrasonography DIAGNOSTIC_TEST

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.

Also known as: Non-invasive ICP monitoring, Ocular ultrasound

Non-Invasive ONSD Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and above admitted to the neurosurgery department.
• Diagnosed with Traumatic Brain Injury, Subarachnoid Hemorrhage, Stroke, Intracranial Hemorrhage, Hydrocephalus, Aneurysm, space occupying lesion of the brain, Empyema, or Pneumocephalus.

You may not qualify if:

• Patients who denied consent.
• Patients with incomplete data or information.
• Presence of coagulopathy or bleeding diathesis.
• Active infection at the site of insertion.
• History of optic nerve lesion or previous optic nerve trauma.
• Inaccessible ultrasound window.
• Skull base fracture with CSF leak.

Sponsors & Collaborators

• Kathmandu Medical College and Teaching Hospital: lead

Study Sites (1)

Kathmandu Medical College

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Intracranial Hypertension; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Hydrocephalus

Interventions

Drug Implants; Ultrasonography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Binod Prasad Joshi, MS

  Kathmandu Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS Resident

Model Details: A prospective comparative cohort study where patients are assigned to either an invasive ICP monitoring group or a non-invasive ONSD monitoring group concurrently, based on the clinical decision of the neurosurgical team.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 15, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available immediately following the publication of the manuscript and will be accessible indefinitely.
• Access Criteria: The datasets analyzed in this study are available from the corresponding author on request. Researchers should direct their requests to Nischal Mainali at nischal.mainali16@gmail.com.

Locations

NE (1)