Intracranial HypertensionNCT07853963
Invasive Versus Non-Invasive Intracranial Pressure-Guided Management in Neurosurgical Patients
A study testing External Ventricular Drain (EVD) Placement and ICP Monitoring and Optic Nerve Sheath Diameter (ONSD) Ultrasonography in people with Intracranial Hypertension and Traumatic Brain Injury, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension, Traumatic Brain Injury, Subarachnoid Haemorrhage (SAH)
- What is being tested?
- External Ventricular Drain (EVD) Placement and ICP Monitoring and Optic Nerve Sheath Diameter (ONSD) Ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invasive Versus Non-Invasive Intracranial Pressure Guided Management and Neurological Outcomes in Neurosurgical Patients: A Prospective Comparative Study
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:
Read more
- 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.
- 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.
Read the detailed description
Raised intracranial pressure (ICP) is one of the most feared complications in neurosurgical practice, capable of critically reducing cerebral perfusion and leading to secondary brain injury. While invasive ICP monitoring through an external ventricular drain (EVD) remains the gold standard for real-time decision-making and therapeutic cerebrospinal fluid (CSF) drainage, it requires surgical expertise and carries risks such as hemorrhage and infection. Non-invasive alternatives, particularly optic nerve sheath diameter (ONSD) ultrasonography, have emerged as rapid, bedside-based, and repeatable tools for estimating ICP, especially in resource-limited settings.
This prospective, comparative cohort study evaluates the clinical and neurological outcomes of neurosurgical patients managed with either invasive ICP monitoring or non-invasive ONSD monitoring.
The study enrolled 40 adult neurosurgical patients (aged 18 and above) presenting with conditions such as traumatic brain injury, subarachnoid hemorrhage, intracranial hemorrhage, and hydrocephalus at Kathmandu Medical College Teaching Hospital. Based on the clinical decision of the attending neurosurgical team, patients were assigned to one of two management arms:
Group A (Invasive): Received standard aseptic placement of an EVD or cisternal drain connected to a pressure transducer. ICP was monitored continuously, and therapeutic CSF drainage was utilized as an active, tier-1 ICP-control measure when thresholds were exceeded.
Group B (Non-Invasive): Received serial bedside ONSD measurements using a high-frequency (7.5 MHz) linear ultrasound probe. Measurements were taken at strict intervals (hourly for 24 hours, four-hourly up to 72 hours, and twice daily up to day 5) or upon signs of neurological deterioration to guide tiered medical management, such as hyperosmolar therapy and controlled hypocapnia.
DOCX
Clinical parameters, including Glasgow Coma Scale (GCS) scores, mean arterial pressure (MAP), and the use of osmotic agents, were recorded concurrently. The primary objective of the study is to evaluate the trajectory of neurological recovery between the two monitoring modalities by tracking daily GCS trends. Secondary objectives include comparing functional outcomes at hospital discharge using the Glasgow Outcome Scale (GOS) and modified Rankin Scale (mRS), assessing the total hospital length of stay, and recording the incidence of procedure-related complications and secondary neurological deterioration.
- Conditions
- Intracranial Hypertension, Traumatic Brain Injury, Subarachnoid Haemorrhage (SAH), Intracerebral Haemorrhage, Hydrocephalus
- Being tested
- External Ventricular Drain (EVD) Placement and ICP Monitoring, Optic Nerve Sheath Diameter (ONSD) Ultrasonography
- Keywords
- Intracranial pressure, Optic nerve sheath diameter, Glasgow Coma Scale, External ventricular drain, Ultrasonography
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Ventricular Drain (EVD) Placement and ICP MonitoringProcedure or surgery
Also called Invasive ICP Monitoring, Therapeutic CSF Drainage
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.
Optic Nerve Sheath Diameter (ONSD) UltrasonographyDiagnostic test
Also called Non-invasive ICP monitoring, Ocular ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice daily (9 AM and 9 PM) for 5 consecutive days following admission
Secondary outcomes (4)
Functional Outcome Assessed by Glasgow Outcome Scale (GOS)
Functional recovery assessed using the GOS, which ranges from 1 (death) to 5 (good recovery). A score of 4 or 5 is considered a favorable outcome. Higher scores indicate better functional recovery.
Measured: At the time of hospital discharge (an average of 11 to 15 days)
Functional Outcome Assessed by Modified Rankin Scale (mRS)
Degree of disability or dependence in daily activities evaluated using the mRS. The scale ranges from 0 (no symptoms) to 6 (dead). A score of 3 or less is considered a good recovery. Lower scores indicate better functional outcomes.
Measured: At the time of hospital discharge (an average of 11 to 15 days)
Length of Hospital Stay
Total duration of the patient's hospital stay measured in days to evaluate the efficiency of the monitoring modalities.
Measured: From hospital admission to hospital discharge (average of 11 to 15 days)
Incidence of Mortality and Medical/Procedural Complications
The number of participants experiencing overall mortality, procedure-related complications (such as EVD tract hemorrhage or meningitis), pneumonia, or secondary neurological deterioration during their admission.
Measured: From hospital admission to hospital discharge (average of 11 to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binod Prasad Joshi, Kathmandu Medical College and Teaching Hospital
- Investigators
- Binod Prasad Joshi, MS, Principal investigator, Kathmandu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853963
- Sponsor's protocol ID
- 101123/22
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets analyzed during the current study will be available to other researchers. All shared data will be de-identified to maintain participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Versus Non-Invasive Intracranial Pressure Guided Management and Neurological Outcomes in Neurosurgical Patients: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07853963
- Acronym / sponsor ID
- 101123/22
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kathmandu Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Raised intracranial pressure (ICP) is one of the most feared complications in neurosurgical practice, capable of critically reducing cerebral perfusion and leading to secondary brain injury. While invasive ICP monitoring through an external ventricular drain (EVD) remains the gold standard for real-time decision-making and therapeutic cerebrospinal fluid (CSF) drainage, it requires surgical expertise and carries risks such as hemorrhage and infection. Non-invasive alternatives, particularly optic nerve sheath diameter (ONSD) ultrasonography, have emerged as rapid, bedside-based, and repeatable tools for estimating ICP, especially in resource-limited settings.
This prospective, comparative cohort study evaluates the clinical and neurological outcomes of neurosurgical patients managed with either invasive ICP monitoring or non-invasive ONSD monitoring.
The study enrolled 40 adult neurosurgical patients (aged 18 and above) presenting with conditions such as traumatic brain injury, subarachnoid hemorrhage, intracranial hemorrhage, and hydrocephalus at Kathmandu Medical College Teaching Hospital. Based on the clinical decision of the attending neurosurgical team, patients were assigned to one of two management arms:
Group A (Invasive): Received standard aseptic placement of an EVD or cisternal drain connected to a pressure transducer. ICP was monitored continuously, and therapeutic CSF drainage was utilized as an active, tier-1 ICP-control measure when thresholds were exceeded.
Group B (Non-Invasive): Received serial bedside ONSD measurements using a high-frequency (7.5 MHz) linear ultrasound probe. Measurements were taken at strict intervals (hourly for 24 hours, four-hourly up to 72 hours, and twice daily up to day 5) or upon signs of neurological deterioration to guide tiered medical management, such as hyperosmolar therapy and controlled hypocapnia.
DOCX
Clinical parameters, including Glasgow Coma Scale (GCS) scores, mean arterial pressure (MAP), and the use of osmotic agents, were recorded concurrently. The primary objective of the study is to evaluate the trajectory of neurological recovery between the two monitoring modalities by tracking daily GCS trends. Secondary objectives include comparing functional outcomes at hospital discharge using the Glasgow Outcome Scale (GOS) and modified Rankin Scale (mRS), assessing the total hospital length of stay, and recording the incidence of procedure-related complications and secondary neurological deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Invasive ICP Monitoring Group | Active comparator | Procedure: External Ventricular Drain (EVD) Placement and ICP MonitoringPatients 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. |
| Non-Invasive ONSD Monitoring Group | Experimental | Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) UltrasonographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Ventricular Drain (EVD) Placement and ICP MonitoringAlso: Invasive ICP Monitoring, Therapeutic CSF DrainageFollowing 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. | Procedure or surgery | Invasive ICP Monitoring Group |
| Optic Nerve Sheath Diameter (ONSD) UltrasonographyAlso: Non-invasive ICP monitoring, Ocular ultrasoundBedside 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. | Diagnostic test | Non-Invasive ONSD Monitoring Group |
Primary outcome
Trajectory of Neurological Recovery Assessed by Glasgow Coma Scale (GCS) Score
Time frame: Twice daily (9 AM and 9 PM) for 5 consecutive days following admission
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.
4 secondary outcomes
Functional Outcome Assessed by Glasgow Outcome Scale (GOS)
Time frame: At the time of hospital discharge (an average of 11 to 15 days)
Functional Outcome Assessed by Modified Rankin Scale (mRS)
Time frame: At the time of hospital discharge (an average of 11 to 15 days)
Length of Hospital Stay
Time frame: From hospital admission to hospital discharge (average of 11 to 15 days)
Incidence of Mortality and Medical/Procedural Complications
Time frame: From hospital admission to hospital discharge (average of 11 to 15 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. The datasets analyzed during the current study will be available to other researchers. All shared data will be de-identified to maintain participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binod Prasad Joshi, MS principal investigator
Kathmandu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Ventricular Drain (EVD) Placement and ICP Monitoring and Optic Nerve Sheath Diameter (ONSD) Ultrasonography in people with Intracranial Hypertension and Traumatic Brain Injury, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trajectory of Neurological Recovery Assessed by Glasgow Coma Scale (GCS) Score (time frame: Twice daily (9 AM and 9 PM) for 5 consecutive days following admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.