Intracranial HypertensionIMPRESSITNCT02322970
Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial (IMPRESSIT)
An observational study of Intracranial Hypertension, run by Università degli Studi di Brescia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- transcranial Doppler
- Type of treatment
- Medical device
- How many people
- 490 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with brain injury, at risk of developing intracranial hypertension, requiring invasive intracranial pressure monitoring.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Spedali Civili, Neuro Critical Care Unit.
Brescia, 25100
Frank Rasulo, frank.rasulo@gmail.com
About this study
Official title: Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial
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.
- Conditions
- Intracranial Hypertension
- Being tested
- transcranial Doppler
- Keywords
- intracranial hypertension, tcd, non invasive, ICP
- Medical subject headings
- Intracranial Hypertension, Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial DopplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Pressure monitoring | Invasive Intracranial Pressure monitoring will be compared to non invasive intracranial monitoring ( through use of transcranial Doppler ). Receives: Device: transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (2)
ROC curve ICPtcd versus ICP
Identify the best fitting ROC curve for ICP tcd in identifying intracranial hypertension.
Measured: 6 hours
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start1 Jul 2017
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Rita Bertuetti, Chiara Robba
- Responsible party
- Principal investigator, Dr. Frank Rasulo, Università degli Studi di Brescia
- Investigators
- Frank A Rasulo, MD, Principal investigator, Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322970
- Sponsor's protocol ID
- impr14
- Acronym
- IMPRESSIT
- Status last verified
- Jun 2020
- First submitted
- 10 Nov 2014
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Versus Non Invasive Measurement of Intracranial Pressure in Brain Injury Trial
- ClinicalTrials.gov ID
- NCT02322970
- Acronym / sponsor ID
- IMPRESSIT / impr14
- Conditions
- Intracranial Hypertension
- Keywords
- intracranial hypertension, tcd, non invasive, ICP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- Rita Bertuetti, Chiara Robba
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial Pressure monitoring | – | Device: transcranial DopplerInvasive Intracranial Pressure monitoring will be compared to non invasive intracranial monitoring ( through use of transcranial Doppler ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with brain injury, at risk of developing intracranial hypertension, requiring invasive intracranial pressure monitoring.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial DopplerComparison 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. | Device | Intracranial Pressure monitoring |
Primary outcome
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
2 secondary outcomes
ROC curve ICPtcd versus ICP
Time frame: 6 hours
Concordance assessment between the two methods
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 35428353Rasulo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A Rasulo, MD principal investigator
Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension, run by Università degli Studi di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank A Rasulo, MD (+390303995 ext. 841, frank.rasulo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of ICP tcd versus invasive ICP (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.