Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial (IMPRESSIT) (IMPRESSIT)
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|ClinicalTrials.gov Identifier: NCT02322970|
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment|
|Intracranial Hypertension||Device: transcranial Doppler|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||490 participants|
|Official Title:||Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Intracranial Pressure monitoring
Invasive Intracranial Pressure monitoring will be compared to non invasive intracranial monitoring ( through use of transcranial Doppler ).
Device: transcranial Doppler
Comparison of non invasive intracranial pressure (through use of transcranial Doppler ) vs invasive monitoring (through insertion of intracerebral catheters) with the purpose of comparing these two techniques in terms of specificity and sensitivity.
- Sensitivity and Specificity of ICP tcd versus invasive ICP [ Time Frame: 6 hours ]Analysis of specificity,sensitivity, positive predictive value and negative predictive value of trans cranial doppler in ruling out ICP above 22 mmHg (defined as intracranial hypertension) in the three different time frames
- ROC curve ICPtcd versus ICP [ Time Frame: 6 hours ]Identify the best fitting ROC curve for ICP tcd in identifying intracranial hypertension.
- Concordance assessment between the two methods [ Time Frame: 6 hours ]Bland and Altman test between ICP tcd and invasive ICP is run in order to evaluate the concordance between gold standard (invasive ICP) and tcd based method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322970
|Contact: Frank A Rasulo, MD||+390303995 ext firstname.lastname@example.org|
|Spedali Civili, Neuro Critical Care Unit.||Recruiting|
|Brescia, Italy, 25100|
|Contact: Frank Rasulo email@example.com|
|Principal Investigator:||Frank A Rasulo, MD||Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy|