Enhanced-contrast Brain Ultrasound in Cardiorespiratory Arrest

NCT ID: NCT04294316

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-31

Brief Summary

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Brain microcirculation alterations may be involved in comatose patients and non-survivors after cardiorespiratory arrest. For a three day-period, we investigate brain microcirculation using contrast-enhanced ultrasound with contrast Sonovue injection in patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.

Detailed Description

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Brain ultrasound, extracranial echo-color duplex and ocular ultrasound (IE 33, Philips Medical System, the Netherlands) are performed in the first 24 hours, at 48 hours, and at 72-96 hours after successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.

Ultrasound examinations are performed in four steps to 1) evaluate the global cerebral blood volume, 2) to estimate the presence or absence of cerebral autoregulation, and 3) to qualitatively evaluate the cerebral perfusion and microcirculation by enhanced microbubbles contrast injection 4) to qualitatively evaluate the intracranial pressure.

Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate the cardiac output (L/min).

First, the global cerebral blood volume (L/min) is evaluated as the sum of flow volumes of the internal carotid (ICA) and vertebral arteries (VA) extracranial arteries of both sides.The following measurements of flow velocities are taken in each artery: Peak systolic and end-diastolic velocity, time-averaged velocity (TAV), Pulsatility Index (PI). Flow volume (Q) of each artery is determined as Q = TAV x Area ((diameter of the artery /2)² x PI).

Brain ultrasound is performed via temporal windows to measure the mean flow velocities (cm/sec) of the middle cerebral arteries.

Second, the presence or absence of cerebral autoregulation is tested with the Transient hyperemic response by an ipsilateral common carotid compression one side and another during 5 seconds. Absence of cerebral autoregulation is considered if the flow velocity of the middle cerebral artery do not increase more than 10% after the compression.

Third, the brain regional microcirculation is evaluated by the microbubbles contrast injection of Sonovue. The brain parenchyma is insonated via the temporal bone windows at the depth of 10cm with the ultrasound S5 multifrequency transducer 2-5 Megahertz (MHz) probe. After optimizing the acoustic bone window, Sonovue is injected intravenously as a bolus 2.4ml followed by 10ml saline flushed. The contralateral brain is evaluated 5 minutes after the first injection of Sonovue to allow a complete evacuation of contrast microbubbles.

All real-time images are stored digitally on the hard disk as DICOM (Digital Image Communications in Medicine) images. Offline imaging analysis using a specific quantification software named QLAB10 (Philips Medical System, the Netherlands) to convert brain perfusion images into time-intensity curves (TIC) corresponding to the five different regions of interest (ROI) of brain parenchyma: anterior and posterior thalamus, lentiform nucleus, parieto-temporal and posterior white matter. Four variables were extracted from these TIC curves to qualitatively evaluate the brain microcirculation: peak intensity in dB, time to peak intensity in seconds, mean transit time in seconds (MTT), and area under the curve in percentage (AUC).

To qualitatively evaluate the intracranial pressure, ocular ultrasound is performed to measure the change of the optic nerve sheath diameter(mm). Elevation of intracranial pressure is considered if this diameter is above 0.55 mm

Conditions

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Cardiorespiratory Arrest Microcirculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound with sulphur hexafluoride microbubbles contrast Sonovue examination
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sonovue group

ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound, extracranial echo-color duplex, and ocular ultrasound.

Group Type OTHER

Sonovue

Intervention Type DIAGNOSTIC_TEST

Twice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation

Interventions

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Sonovue

Twice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest

Exclusion Criteria

* Younger than 18 years old
* Pregnancy
* Acute or history of neurological disorder: stroke, bleeding, trauma, post-neurosurgery, tumor, meningitis.
* Severe dementia, psychiatric or neuromuscular disability
* Untreated Acute coronary syndrome
* Acute Respiratory Distress Syndrome (ARDS) with the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (PaO2/ FiO2) less than 150
* Severe systolic pulmonary hypertension above 90 mmHg
* Advanced liver cirrhosis with hyperammonemia
* Uremia \> 200mmol/L
* Acute drug intoxications with coma
* Acute alcohol intoxication or withdrawal syndrome.
* Advanced malign diseases.
* History of allergy to the microbubble contrast SONOVUE.
* Insufficient echogenicity to ultrasound and incomplete insonation of the intracerebral arteries and brain parenchyma.
* Significant intracerebral and extracerebral arteries stenosis (≥ 70%) or vertebral artery hypoplasia (3mm).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Duc Nam Nguyen

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duc Nam Nguyen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair ziekenhuis Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Duc Nam Nguyen, MD, PhD

Role: CONTACT

3224763037

Godelieve Opdenacker, Study nurse

Role: CONTACT

Facility Contacts

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Marie-Claire Van Malderen, Stidy nurse

Role: primary

003224775117

Godelieve Opdenacker, Study nurse

Role: backup

003224775117

References

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Robba C, Goffi A, Geeraerts T, Cardim D, Via G, Czosnyka M, Park S, Sarwal A, Padayachy L, Rasulo F, Citerio G. Brain ultrasonography: methodology, basic and advanced principles and clinical applications. A narrative review. Intensive Care Med. 2019 Jul;45(7):913-927. doi: 10.1007/s00134-019-05610-4. Epub 2019 Apr 25.

Reference Type BACKGROUND
PMID: 31025061 (View on PubMed)

Piscaglia F, Nolsoe C, Dietrich CF, Cosgrove DO, Gilja OH, Bachmann Nielsen M, Albrecht T, Barozzi L, Bertolotto M, Catalano O, Claudon M, Clevert DA, Correas JM, D'Onofrio M, Drudi FM, Eyding J, Giovannini M, Hocke M, Ignee A, Jung EM, Klauser AS, Lassau N, Leen E, Mathis G, Saftoiu A, Seidel G, Sidhu PS, ter Haar G, Timmerman D, Weskott HP. The EFSUMB Guidelines and Recommendations on the Clinical Practice of Contrast Enhanced Ultrasound (CEUS): update 2011 on non-hepatic applications. Ultraschall Med. 2012 Feb;33(1):33-59. doi: 10.1055/s-0031-1281676. Epub 2011 Aug 26. No abstract available.

Reference Type BACKGROUND
PMID: 21874631 (View on PubMed)

Harrois A, Duranteau J. Contrast-enhanced ultrasound: a new vision of microcirculation in the intensive care unit. Crit Care. 2013 Aug 23;17(4):449. doi: 10.1186/cc12860.

Reference Type BACKGROUND
PMID: 24103639 (View on PubMed)

Seidel G, Meairs S. Ultrasound contrast agents in ischemic stroke. Cerebrovasc Dis. 2009;27 Suppl 2:25-39. doi: 10.1159/000203124. Epub 2009 Apr 16.

Reference Type BACKGROUND
PMID: 19372658 (View on PubMed)

Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.

Reference Type BACKGROUND
PMID: 18509619 (View on PubMed)

Other Identifiers

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B.U.N 143201941163

Identifier Type: -

Identifier Source: org_study_id

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