Cerebral Compliance Impairment in COVID-19

NCT04429477 | Completed FDA Device

• 1 other identifier: 31750820.1.0000.0068
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Several recent studies point to the possibility of the new coronavirus (SARS-Cov2), which currently causes pandemic COVID-19, to infiltrate the central nervous system (CNS) and cause primary damage to neural tissues, increasing the morbidity and mortality of these patients. A pathophysiological hypothesis for insulting the CNS would be the impairment of cerebral compliance (CC), because elevation of intracranial pressure (ICP), but due to the invasive nature of the methods available for ICP evaluation, this hypothesis has so far not been verified. Recently, a noninvasive technique was developed to evaluate CC (B4C sensor), making it possible to analyse CC in patients outside the neurosurgical environment. Therefore, the main objective of this study was to assess the presence of CC impairment in patients with COVID-19, and observe potential influences of this syndrome on cerebral hemodynamics.

Conditions

Intracranial Hypertension; Cerebral Circulatory Failure

Outcome Measures

Primary Outcomes (2)

• Detection of cerebral compliance impairment by the B4C sensor

  Observe alteration in cerebral compliance due to potential intracranial hypertension during severe COVID-19. This situation is indicated when the relation P2/P1 given by the B4C sensor is \>1.

  During critical care, around 15 days/patient

• Detection of cerebral hemodynamics impairment by transcranial Doppler

  Observe disturbances in cerebral circulation during severe COVID-19, given by blood flow velocities in middle cerebral arteries (with normal range 40-70 cm/s) and the pulsatility index (normal \<1.2) calculated by transcranial Doppler.

  During critical care, around 15 days/patient

Secondary Outcomes (1)

• Calculate mortality in this population

  3 months

Interventions

Cerebral compliance and hemodynamics monitoring DEVICE

Noninvasive devices are been used to assess cerebral circulation and compliance.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible subjects were selected by the ICU team during the first three days of orotracheal intubation for CC monitoring with B4C and TCD hemodynamics evaluation once, marking the beginning of SARS. The same evaluations were repeated once again during the first three days after orotracheal tube withdrawal, as a sign of recovery stage. Clinical parameters were controlled to avoid assessment bias, as systemic arterial pressure, hydric balance, presence of CNS depressors with influence on cerebrovascular hemodynamics, laboratorial partial O2 and CO2 pressures and hemoglobin, and temperature. One operator is performing TCD and B4C evaluations. Overall sample clinical condition is quantified using the simplified acute physiologic score (SAPS 3). Each subject undergone a skull CT scan in order to exclude a mass effect lesion not related to COVID-19.

You may qualify if:

• patients with SARS for COVID-19, under ventilatory support of any age and gender

You may not qualify if:

• the absence of legally authorized responsible (LAR) consent,
• patients without temporal acoustic window for TCD assessment,
• patients unable to undergo monitoring with the NICC sensor due to lesions and/or skin infections in the sensor application region,
• patients with head circumference smaller than 47 cm.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP.

São Paulo, 05403000, Brazil

Location

Related Publications (13)

• Li YC, Bai WZ, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020 Jun;92(6):552-555. doi: 10.1002/jmv.25728. Epub 2020 Mar 11.

  PMID: 32104915 BACKGROUND

• Baig AM, Khaleeq A, Ali U, Syeda H. Evidence of the COVID-19 Virus Targeting the CNS: Tissue Distribution, Host-Virus Interaction, and Proposed Neurotropic Mechanisms. ACS Chem Neurosci. 2020 Apr 1;11(7):995-998. doi: 10.1021/acschemneuro.0c00122. Epub 2020 Mar 13.

  PMID: 32167747 BACKGROUND

• Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.

  PMID: 32346843 BACKGROUND

• Bridwell R, Long B, Gottlieb M. Neurologic complications of COVID-19. Am J Emerg Med. 2020 Jul;38(7):1549.e3-1549.e7. doi: 10.1016/j.ajem.2020.05.024. Epub 2020 May 16.

  PMID: 32425321 BACKGROUND

• Niazkar HR, Zibaee B, Nasimi A, Bahri N. The neurological manifestations of COVID-19: a review article. Neurol Sci. 2020 Jul;41(7):1667-1671. doi: 10.1007/s10072-020-04486-3. Epub 2020 Jun 1.

  PMID: 32483687 BACKGROUND

• Wu Y, Xu X, Chen Z, Duan J, Hashimoto K, Yang L, Liu C, Yang C. Nervous system involvement after infection with COVID-19 and other coronaviruses. Brain Behav Immun. 2020 Jul;87:18-22. doi: 10.1016/j.bbi.2020.03.031. Epub 2020 Mar 30.

  PMID: 32240762 BACKGROUND

• Delanghe JR, Speeckaert MM, De Buyzere ML. The host's angiotensin-converting enzyme polymorphism may explain epidemiological findings in COVID-19 infections. Clin Chim Acta. 2020 Jun;505:192-193. doi: 10.1016/j.cca.2020.03.031. Epub 2020 Mar 24. No abstract available.

  PMID: 32220422 BACKGROUND

• Kochanek PM, Tasker RC, Carney N, Totten AM, Adelson PD, Selden NR, Davis-O'Reilly C, Hart EL, Bell MJ, Bratton SL, Grant GA, Kissoon N, Reuter-Rice KE, Vavilala MS, Wainwright MS. Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines, Executive Summary. Neurosurgery. 2019 Jun 1;84(6):1169-1178. doi: 10.1093/neuros/nyz051.

  PMID: 30822776 BACKGROUND

• Frigieri G, Andrade RAP, Dias C, Spavieri DL Jr, Brunelli R, Cardim DA, Wang CC, Verzola RMM, Mascarenhas S. Analysis of a Non-invasive Intracranial Pressure Monitoring Method in Patients with Traumatic Brain Injury. Acta Neurochir Suppl. 2018;126:107-110. doi: 10.1007/978-3-319-65798-1_23.

  PMID: 29492543 BACKGROUND

• Vilela GH, Cabella B, Mascarenhas S, Czosnyka M, Smielewski P, Dias C, Cardim DA, Mascarenhas YM, Wang CC, Andrade R, Tanaka K, Lopes LS, Colli BO. Validation of a New Minimally Invasive Intracranial Pressure Monitoring Method by Direct Comparison with an Invasive Technique. Acta Neurochir Suppl. 2016;122:97-100. doi: 10.1007/978-3-319-22533-3_19.

  PMID: 27165885 BACKGROUND

• Cabella B, Vilela GH, Mascarenhas S, Czosnyka M, Smielewski P, Dias C, Cardim DA, Wang CC, Mascarenhas P, Andrade R, Tanaka K, Silva Lopes L, Colli BO. Validation of a New Noninvasive Intracranial Pressure Monitoring Method by Direct Comparison with an Invasive Technique. Acta Neurochir Suppl. 2016;122:93-6. doi: 10.1007/978-3-319-22533-3_18.

  PMID: 27165884 BACKGROUND

• Schaafsma A. A new method for correcting middle cerebral artery flow velocity for age by calculating Z-scores. J Neurosci Methods. 2018 Sep 1;307:1-7. doi: 10.1016/j.jneumeth.2018.06.009. Epub 2018 Jun 18.

  PMID: 29920296 BACKGROUND

• Schaafsma A. Improved parameterization of the transcranial Doppler signal. Ultrasound Med Biol. 2012 Aug;38(8):1451-9. doi: 10.1016/j.ultrasmedbio.2012.03.016. Epub 2012 May 12.

  PMID: 22579541 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: May 1, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 31, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)