Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Compliance Impairment in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429477
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sergio Brasil, MD, University of Sao Paulo

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.

Condition or disease Intervention/treatment
Intracranial Hypertension Cerebral Circulatory Failure Device: Cerebral compliance and hemodynamics monitoring

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Assessment of Cerebral Compliance and Hemodynamics in Severe COVID-19
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Cerebral compliance and hemodynamics monitoring
    Noninvasive devices are been used to assess cerebral circulation and compliance.


Primary Outcome Measures :
  1. Detection of cerebral compliance impairment by the B4C sensor [ Time Frame: During critical care, around 15 days/patient ]
    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.

  2. Detection of cerebral hemodynamics impairment by transcranial Doppler [ Time Frame: During critical care, around 15 days/patient ]
    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.


Secondary Outcome Measures :
  1. Calculate mortality in this population [ Time Frame: 3 months ]
    Observe whether disturbances in cerebral compliance and hemodynamics assessed in this population is significantly associated with higher mortality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429477


Locations
Layout table for location information
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP.
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Publications:

Layout table for additonal information
Responsible Party: Sergio Brasil, MD, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04429477    
Other Study ID Numbers: 31750820.1.0000.0068
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Hypertension
Shock
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes