NCT02322970

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

5.1 years

First QC Date

November 10, 2014

Last Update Submit

June 29, 2020

Conditions

Intracranial Hypertension

Keywords

intracranial hypertensiontcdnon invasiveICP

Outcome Measures

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

    6 hours

Secondary Outcomes (2)

  • ROC curve ICPtcd versus ICP

    6 hours

  • Concordance assessment between the two methods

    6 hours

Study Arms (1)

Intracranial Pressure monitoring

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

Device: transcranial Doppler

Interventions

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.

Intracranial Pressure monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with brain injury, at risk of developing intracranial hypertension, requiring invasive intracranial pressure monitoring.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spedali Civili, Neuro Critical Care Unit.

Brescia, 25100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35428353DERIVED

MeSH Terms

Conditions

Intracranial HypertensionChoroideremia

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Frank A Rasulo, MD

    Neuro-Intensive Care, Spedali Civili Accademic Hospital, University of Brescia, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank A Rasulo, MD

CONTACT

+390303995frank.rasulo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NEURO CRITICAL CARE UNIT'S CHIEF

Study Record Dates

First Submitted

November 10, 2014

First Posted

December 23, 2014

Study Start

July 1, 2017

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

IT(1)