CClinicalTrials.gg
Status unknownNCT02322970IMPRESSITUpdated Jul 1, 2020

Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial (IMPRESSIT)

An observational study in Intracranial Hypertension, sponsored by Università degli Studi di Brescia. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-01.

Sponsored by Università degli Studi di Brescia · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
490
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

As part of intensive treatment of brain injury, intracranial pressure (ICP) should be controlled when the cerebral perfusion pressure (CPP) falls below 60-70 millimeters of mercury (mmHg) (depending on the cause of injury) and/or the ICP is greater than 20 mmHg. Intracranial hypertension (ICHP) occurs in approximately 30-40% of all patients with severe traumatic brain injury and it is not infrequent in patients with non traumatic brain injury, such as subarachnoid hemorrhage (SAH), spontaneous intracerebral hemorrhage (SICH), and ischemic stroke (IS), and the presence of ICHP and inadequate CPP has been correlated to poor outcome. Therefore, measures to monitor ICP and CPP should be instituted as soon as possible in patients with severe brain injury. Currently, available methods for ICP monitoring include epidural, subdural, subarachnoid, parenchymal, and ventricular locations. Historically, ventricular ICP catheter has been used as the reference standard and the preferred technique when possible. It is the most accurate, and reliable method of monitoring ICP. Subarachnoid, subdural, and epidural monitors are less accurate. Unfortunately, all of the described methods are invasive, associated with a complication rate and are not inexpensive. For this reason, new methods have been developed in order to measure ICP non invasively. Transcranial Doppler (TCD) allows insonation of the basal cerebral arteries and the measurement of blood flow velocities in such vessels in by using a low-frequency-pulsed Doppler of 2 Mega Hertz (MHz) over the acoustic window regions. Many authors have analysed the doppler wave shape and the relation among diastolic, systolic and mean velocities in order to find a correlation with ICP and CPP. Few formulas have been described, in our study, the method introduced and tested by Schmidt et Al. in 2000 was adopted. Those authors observed a relationship among mean arterial blood pressure (ABP) diastolic flow velocity (FVd) and mean flow velocity (FVm) in the middle cerebral artery (MCA) that led them to find a formula able to yield CPP (estimated CPP: ABP x FVd / FVm + 14); once CPP is estimated, ICPtcd is easily calculated (ICP= ABP- CPP). The first aim of our study is to evaluate the sensitivity and specificity of ICPtcd, compared to invasive ICP measurement, in order to exclude elevated ICP in patients with acute brain injury such as epidural hematomas (EDH), subdural hematomas (SDH), subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH), ischaemic strokes (IS), traumatic brain injury (TBI). Inclusion criteria are:

  • acute brain injury requiring invasive ICP monitoring
  • Age > 18 yrs.

Exclusion criteria are:

  • inaccessible or poor acoustic ultrasound window;
  • a cardiovascular disease causing hemodynamic variations affecting the TCD reading (severe arrhythmia, severe cardiac valvular stenosis, moderate or severe vasospasm);
  • patients receiving craniotomy or had craniectomy before first time frame 1°,
  • any treatment for intracranial hypertension or manipulation of arterial blood pressure between the non-invasive ICPtcd measurements and the invasive ICP (ICPi) measurement. (This is most likely to happen during time frame 1°).

All patients included will have evaluation of non-invasive ICP monitoring through use of TCD (ICPtcd), and at least three TCD Measurements will be performed and correlated with non-invasive ICP. The timing for the TCD measurements and correlations will be as follows:

  • 1° measurement: will be performed before, and as close as possible, to ICP monitoring probe placement.
  • 2° measurement. Immediately following ICP monitoring probe placement;
  • 3° measurement: after ICP management optimization (2-3 hours after the second measurement).

The first brain CT will be performed before invasive ICP placement (this CT scan is normally performed for diagnostic purposes) and whenever it is appropriate to perform the second scan, either for a change in clinical status, or according to guidelines and clinical judgment. If possible from 8 - 12 hrs following the first scan.

02

Conditions studied

  • Intracranial Hypertension

Keywords

  • intracranial hypertension
  • tcd
  • non invasive
  • ICP
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 490 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Università degli Studi di Brescia is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
490 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intracranial Pressure monitoring

    Invasive Intracranial Pressure monitoring will be compared to non invasive intracranial monitoring ( through use of transcranial Doppler ).

    Device: transcranial Doppler

Interventions

  • Devicetranscranial 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.

06

What researchers measure

Primary outcomes

  1. Sensitivity and Specificity of ICP tcd versus invasive ICP

    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

    Time frame: 6 hours

Secondary outcomes

  1. ROC curve ICPtcd versus ICP

    Identify the best fitting ROC curve for ICP tcd in identifying intracranial hypertension.

    Time frame: 6 hours

  2. Concordance assessment between the two methods

    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

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • Spedali Civili, Neuro Critical Care Unit.
    Brescia, 25100, Italy
    Recruiting
08

References and documents

Publications

  • Rasulo FA, Calza S, Robba C, Taccone FS, Biasucci DG, Badenes R, Piva S, Savo D, Citerio G, Dibu JR, Curto F, Merciadri M, Gritti P, Fassini P, Park S, Lamperti M, Bouzat P, Malacarne P, Chieregato A, Bertuetti R, Aspide R, Cantoni A, McCredie V, Guadrini L, Latronico N. Transcranial Doppler as a screening test to exclude intracranial hypertension in brain-injured patients: the IMPRESSIT-2 prospective multicenter international study. Crit Care. 2022 Apr 15;26(1):110. doi: 10.1186/s13054-022-03978-2. PubMed 35428353 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02322970
Lead sponsor
Università degli Studi di Brescia
Collaborators
Rita Bertuetti, Chiara Robba
Responsible party
Dr. Frank Rasulo (NEURO CRITICAL CARE UNIT'S CHIEF, Università degli Studi di Brescia) — Principal investigator
First posted
Dec 23, 2014
Start date
Jul 1, 2017
Primary completion
Jul 31, 2022 (estimated)
Completion
Jul 31, 2022 (estimated)
Last update
Jul 1, 2020

Study contacts

Frank A Rasulo, MD
Contact
frank.rasulo@gmail.com
+390303995 ext. 841
Frank A Rasulo, MD
principal investigator · Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion