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Completed
NCT07853963
Invasive Versus Non-Invasive Intracranial Pressure-Guided Management in Neurosurgical Patients
Conditions: Intracranial Hypertension, Traumatic Brain Injury, Subarachnoid Haemorrhage (SAH), Intracerebral Haemorrhage, Hydrocephalus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Kathmandu Medical College and Teaching Hospital
Location: Kathmandu Medical College Kathmandu Bagmati
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07853963). StuddyBuddy aggregates publicly available trial information.