Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP

Study Overview
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Brief Summary
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Osmotherapy with mannitol has been a common practice in patients with raised ICP. Monitoring its effect on ICP can be performed invasively and non-invasively. Due to a validated correlation between invasive ICP monitoring and ONSD measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on ICP. This study examines the acute changes in sonographically measured ONSD brought about by the administration of mannitol. This can correlate with the changes in ICP in such patients and can be utilized as a tool for decision making/ point-of-care utility.

Detailed Description
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This is a prospective cohort based observational study including 40 patients admitted in the adult ICU at our center diagnosed as either a case of TBI/ acute stroke/ intracranial hemorrhages with a mean screening ONSD of more than 5mm under mannitol osmotherapy. ONSD were measured by a high frequency linear array probe (>10 Hz) at the time of screening. Mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. ONSDs were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. Demographic data, baseline ventilator parameters of patients on mechanical ventilation, GCS and mean arterial pressure at each time points were recorded. Comparison of variables at these time points were made.

Official Title
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Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure

Conditions
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Raised Intracranial Pressure

Intervention / Treatment
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* Device: Optic nerve sheath diameter measurement
* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years diagnosed as a case of TBI/ acute stroke/ intracranial hemorrhages screening mean ONSD > 5 mm under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg) Exclusion Criteria: baseline ocular pathology like tumors, Graves' disease and sarcoidosis previous ocular surgery Decompressive cranial surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optic nerve sheath diameter measurement|ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)|
|Drug: Mannitol|Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration | Change in optic nerve sheath diameter (ONSD) | 30, 60 and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change in ONSD and Mean arterial pressure | Correlation with change in ONSD and Mean arterial pressure | 30, 60, and 120 minutes | 
| Correlation between dose and change in ONSD | Dose subgroups of <0.5gm/kg and >/= 0.5 gm/kg were compared and the correlated with changes in ONSD. | 30, 60 and 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICP, ONSD, Mannitol