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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
Sponsor:
Collaborators:
Rita Bertuetti
Chiara Robba
Information provided by (Responsible Party):
Dr. Frank Rasulo, Università degli Studi di Brescia

Brief Summary:
Investigators aim to assess sensitivity and specificity of transcranial doppler in ruling out intracranial hypertension in all patients admitted to intensive care unit for brain injury and needing Intracranial Pressure (ICP) monitoring (according to international guidelines). Non invasive ICP measurement through the use of transcranial doppler will be carried out before and after standard invasive ICP monitoring placement.

Condition or disease Intervention/treatment
Intracranial Hypertension Device: transcranial Doppler

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. ROC curve ICPtcd versus ICP [ Time Frame: 6 hours ]
    Identify the best fitting ROC curve for ICP tcd in identifying intracranial hypertension.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with brain injury, at risk of developing intracranial hypertension, requiring invasive intracranial pressure monitoring.
Criteria

Inclusion Criteria:

  • Brain injury (All patients with brain injury, at risk of developing intracranial hypertension, requiring invasive intracranial pressure monitoring. );
  • Patients requiring invasive ICP monitoring;
  • Age > 18 yrs.

Exclusion Criteria:

  • inaccessible ultrasound window;
  • a cardiovascular disease causing hemodynamic variations affecting the TCD reading (severe arrhythmia, severe cardiac valvular stenosis, moderate or severe vasospasm),
  • Patient already with craniotomy or craniectomy before first time frame 1°,
  • any treatment for intracranial hypertension or manipulation of arterial blood pressure intervening between the non-invasive ICPtcd measurements and the invasive ICP (ICPi) measurement.

Information from the National Library of Medicine

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


Contacts
Contact: Frank A Rasulo, MD +390303995 ext 841 frank.rasulo@gmail.com

Locations
Italy
Spedali Civili, Neuro Critical Care Unit. Recruiting
Brescia, Italy, 25100
Contact: Frank Rasulo       frank.rasulo@gmail.com   
Sponsors and Collaborators
Università degli Studi di Brescia
Rita Bertuetti
Chiara Robba
Investigators
Principal Investigator: Frank A Rasulo, MD Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy

Responsible Party: Dr. Frank Rasulo, NEURO CRITICAL CARE UNIT'S CHIEF, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02322970     History of Changes
Other Study ID Numbers: impr14
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Frank Rasulo, Università degli Studi di Brescia:
intracranial hypertension
tcd
non invasive
ICP

Additional relevant MeSH terms:
Craniocerebral Trauma
Hypertension
Brain Injuries
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries