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Trans-Cranial Doppler as a Screening Test to Exclude Intracranial Hypertension in Brain Injured Patients: The IMPRESSIT-2 Prospective Multicenter International Study

31 Pages Posted: 1 Dec 2021

See all articles by Frank Anthony Rasulo

Frank Anthony Rasulo

Spedali Civili University Hospital

Stefano Calza

University of Brescia - Department of Molecular and Translational Medicine

Chiara Robba

Università degli Studi di Genova

Fabio Silvio Taccone

Université Libre de Bruxelles (ULB) - Department of Intensive Care

Daniele G. Biasucci

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rafael Badenes

University of Valencia - Department of Anesthesiology and Intensive Care

Simone Piva

ASST-Spedali Civili of Brescia - Department of Anesthesia

Davide Savo

ASST - Monza - San Gerardo Hospital

Giuseppe Citerio

ASST - Monza - San Gerardo Hospital

Jamil R. Dibu

Cleveland Clinic - Cerebrovascular center of neurological Institute

Francesco Curto

Grande Ospedale Metropolitano Niguarda - Department of Neurointensive Care

Martina Merciadri

Azienda Ospedaliera Universitaria Pisana - Department of Anesthesiology and Critical Care

Paolo Gritti

Papa Giovanni XXIII Hospital

Paola Fassini

Legnano Hospital

Soojin Park

Columbia University - Division of Hospital and Critical Care Neurology

Massimo Lamperti

affiliation not provided to SSRN

Pierre Bouzat

Grenoble Alpes University Hospital

Paolo Malacarne

affiliation not provided to SSRN

Arturo Chieregato

Grande Ospedale Metropolitano Niguarda

Rita Bertuetti

affiliation not provided to SSRN

Raffaele Aspide

affiliation not provided to SSRN

Alfredo Cantoni

OSPEDALE DI CIRCOLO DI VARESE - ASST-SETTELAGHI

Victoria McCredie

University of Toronto

Lucrezia Guadrini

affiliation not provided to SSRN

Nicola Latronico

ASST-Spedali Civili of Brescia - Intensive Care and Emergency; University of Brescia - Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health

More...

Abstract

Background: The reference standard method for diagnosing intracranial hypertension(IH) is invasive measurement of intracranial pressure. In situations where ICP i is not available, or  contraindicated, non-invasive methods may prove useful; however, their diagnostic accuracy remains debated. This study was conducted to evaluate the accuracy of transcranial Doppler(TCD) as a screening test to exclude IH in acute brain-injured patients.

Methods: This was a prospective, international, multicenter study involving 16 ICUs. Critically ill brain-injured patients were enrolled if they required invasive ICP (ICP i ) monitoring. ICPi measurements (reference test) were compared to simultaneously recorded TCD-based, non-invasive ICP (ICP tcd) measurements (index test) at three different timepoints: before, immediately after and 2 to 3 hours following ICP i catheter insertion. Sensitivity, specificity, positive (PPV) and negative predictive values (NPV) were calculated at three different ICP i thresholds (>20, >22 and >25mmHg) to assess TCD as a bedside real-practice screening method. A receiver operating characteristic (ROC) curve analysis with the area under the curve (AUC) was used to evaluate the discriminative accuracy and predictive capability of ICP tcd.

Findings: A total of 266 patients were recruited, 262 of whom were considered for final analysis. IH(>22 mmHg) occurred in 87 patients(33.2%). The total number of paired comparisons between ICP tcd and ICP i was 687. The NPV was elevated (ICP>20mmHg=91.3%, >22mmHg=95.6%, >25mmHg=98.6%), indicating high discriminant accuracy of ICP tcd in excluding IH. Concordance correlation between ICP tcd and ICP i was 33.3%(95% CI 25.6% - 40.5%) and Bland-Altman showed a mean bias of -3.3 mmHg (limits of agreement between –26.1mmHg and +19.5mmHg). The optimal ICPi threshold for ruling out IH was 20.5 mmHg, corresponding to a sensitivity of 70%(95% CI 40.7%-92.6%) and a specificity of 72%(95% CI 51.9%-94.0%) with an AUC of 76%(95% CI 65.6%-85.5%). 

Interpretation: ICP tcd has a high NPV in ruling out IH in situations where invasive methods cannot be used or not available.

Clinical Trial Registration Details: ClinicalTrials.gov NCT02322970.

Funding Information: None.

Declaration of Interests: None.

Ethics Approval Statement: For the coordinating center of Brescia, Italy, the ethics committee approval was obtained on July 17, 2017 (NP-2762). The study approval was also obtained at each site from local regulatory boards before the study started. Written informed consent was obtained by family representatives. In the Italian centers, the requirement of informed consent was waived, because relatives are not regarded as legal representatives of the patient in the absence of a formal designation. Written informed consent was requested from all surviving patients if, and as soon as, they regained their mental competency.

Keywords: intracranial pressure, non-invasive monitoring, brain injury, IH

Suggested Citation

Rasulo, Frank Anthony and Calza, Stefano and Robba, Chiara and Taccone, Fabio Silvio and Biasucci, Daniele G. and Badenes, Rafael and Piva, Simone and Savo, Davide and Citerio, Giuseppe and Dibu, Jamil R. and Curto, Francesco and Merciadri, Martina and Gritti, Paolo and Fassini, Paola and Park, Soojin and Lamperti, Massimo and Bouzat, Pierre and Malacarne, Paolo and Chieregato, Arturo and Bertuetti, Rita and Aspide, Raffaele and Cantoni, Alfredo and McCredie, Victoria and Guadrini, Lucrezia and Latronico, Nicola, Trans-Cranial Doppler as a Screening Test to Exclude Intracranial Hypertension in Brain Injured Patients: The IMPRESSIT-2 Prospective Multicenter International Study. Available at SSRN: https://ssrn.com/abstract=3965381 or http://dx.doi.org/10.2139/ssrn.3965381

Frank Anthony Rasulo (Contact Author)

Spedali Civili University Hospital ( email )

Italy

Stefano Calza

University of Brescia - Department of Molecular and Translational Medicine ( email )

Brescia
Italy

Chiara Robba

Università degli Studi di Genova ( email )

Via Vivaldi 5
Genova, 16126
Italy

Fabio Silvio Taccone

Université Libre de Bruxelles (ULB) - Department of Intensive Care ( email )

Daniele G. Biasucci

Fondazione Policlinico Universitario A. Gemelli IRCCS ( email )

Italy

Rafael Badenes

University of Valencia - Department of Anesthesiology and Intensive Care ( email )

Spain

Simone Piva

ASST-Spedali Civili of Brescia - Department of Anesthesia

Davide Savo

ASST - Monza - San Gerardo Hospital ( email )

Via Pergolesi 33
Monza
Italy

Giuseppe Citerio

ASST - Monza - San Gerardo Hospital ( email )

Via Pergolesi 33
Monza
Italy

Jamil R. Dibu

Cleveland Clinic - Cerebrovascular center of neurological Institute ( email )

United States

Francesco Curto

Grande Ospedale Metropolitano Niguarda - Department of Neurointensive Care ( email )

United States

Martina Merciadri

Azienda Ospedaliera Universitaria Pisana - Department of Anesthesiology and Critical Care ( email )

United States

Paolo Gritti

Papa Giovanni XXIII Hospital ( email )

Bergamo
Italy

Paola Fassini

Legnano Hospital ( email )

Milan
Italy

Soojin Park

Columbia University - Division of Hospital and Critical Care Neurology ( email )

Massimo Lamperti

affiliation not provided to SSRN ( email )

No Address Available

Pierre Bouzat

Grenoble Alpes University Hospital ( email )

Paolo Malacarne

affiliation not provided to SSRN ( email )

No Address Available

Arturo Chieregato

Grande Ospedale Metropolitano Niguarda ( email )

Rita Bertuetti

affiliation not provided to SSRN ( email )

No Address Available

Raffaele Aspide

affiliation not provided to SSRN ( email )

No Address Available

Alfredo Cantoni

OSPEDALE DI CIRCOLO DI VARESE - ASST-SETTELAGHI ( email )

Italy

Victoria McCredie

University of Toronto ( email )

105 St George Street
Toronto, M5S 3G8
Canada

Lucrezia Guadrini

affiliation not provided to SSRN ( email )

No Address Available

Nicola Latronico

ASST-Spedali Civili of Brescia - Intensive Care and Emergency ( email )

Italy
+39-0303995561 (Phone)
+39-0303995779 (Fax)

University of Brescia - Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health ( email )

Piazza del Mercato
Brescia
Italy

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