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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optic nerve sheath diameter measurement | Device | ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4) |
| |
| Mannitol | Drug | Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of ONSD values among ventilated and non-ventilated patients | Comparison of ONSD values among ventilated and non-ventilated patients at 30,60 and 120 minutes | 30, 60 and 120 minutes |
Inclusion Criteria:
Exclusion Criteria:
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Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study
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| Name | Affiliation | Role |
|---|---|---|
| Shiva P Paudyal, MD | Institution of medicine, Tribhuvan University, Nepal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maharajgunj Medical Campus | Kathmandu | Bagmati | 44600 | Nepal |
Hospital inpatient number, age, sex, weight, BMI, dose of mannitol administered, MAP, ONSD at T1, T2, T3, T4 and change in ONSD T1, T2, T3 and T4.
2 years
Contact with the PI
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 24, 2019 | Nov 9, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| 30, 60 and 120 minutes |