Intracranial HypertensionNCT04429477
Cerebral Compliance Impairment in COVID-19
An observational study of Intracranial Hypertension and Cerebral Circulatory Failure, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Intracranial Hypertension, Cerebral Circulatory Failure
- What is being tested?
- Cerebral compliance and hemodynamics monitoring
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2020to 31 Jul 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patients with SARS for COVID-19, under ventilatory support of any age and gender
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP.
São Paulo, 05403000
About this study
Official title: Assessment of Cerebral Compliance and Hemodynamics in Severe COVID-19
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.
Read the detailed description
The gravity of the disease caused by the new coronavirus 2019 (COVID-19) is predominantly harbored in severe acute respiratory syndrome (SARS), often requiring ventilatory support. However, in some cases it has been observed that the involvement of this entity is not restrict to the respiratory tract, but also to the central nervous system (CNS), heart, kidneys, intestines and testicles, or even the cross-response of the immune system with potential for Guillain-Barre and Miller-Fisher syndromes. It is not yet clear whether acute respiratory failure in patients with COVID-19 is due exclusively to pulmonary invasion or because of concurrent CNS disorders, however, as many of these patients have neurological symptoms such as headache, anosmia, paresthesia, nausea, vomiting and consciousness level alterations during the early stages of the disease, the hypothesis of this entity in promoting cerebral compliance (CC) impairment directly (i.e. encephalitis, edema or focal ischemia) or indirectly (i.e. hypoxic distress and linkage to angiotensin-converting enzyme) becomes suitable.
Intracranial pressure (ICP) monitoring is relevant in several CNS diseases with risk for critical intracranial hypertension (ICH)(10). Still, this parameter is considered in specific situations, limiting its use in neurocritical settings, especially because of the invasive nature of the monitoring techniques available. ICH has potential to compromise CC and, consequently, promote brain tissue damage. Regarding COVID-19, unless a mass effect structural damage documented by encephalic imaging is evident, there is no justification to perform a trepanation to implant an ICP monitor, hence, noninvasive techniques such as transcranial Doppler by means of cerebral hemodynamics evaluation and the novel cranial pulse detector (B4C), by means of the quantitative evaluation of the ICP curves, may play a role in this scenario.
The purpose of the present study was to evaluate CC in a set of COVID-19 patients, since implementation until withdrawal of respiratory support in ICU, to evaluate the potential persistence of CC impairment in this population. Prolonged CC impairment observation may aid decision making and targeted therapy in this population. Study design A single center, observational and prospective research was conducted including consecutive subjects in intensive care units (ICU) of the Hospital das Clínicas, São Paulo University, Brazil, with approval of local ethics committee. Our inclusion criteria regarded patients with SARS for COVID-19, under ventilatory support of any age and gender. Exclusion criteria comprehended 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. The study protocol followed the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement.
Eligible subjects are selected by the ICU team (SF, BT, EB and LMSM) 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 are repeated once again during the first three days after extubating, 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 was quantified using the simplified acute physiologic score (SAPS 3).
CC monitoring techniques Cerebral compliance was evaluated noninvasively by the cranial deformation method developed by brain4care (B4C). The B4C sensor consists of a support for a sensor bar for the detection of local cranial bone deformations adapted with deformation sensors. The detection of these deformations is obtained by a cantilever bar modeled by finite element calculations. For this bar, voltage meters are attached for deformation detection. Noninvasive contact with the skull is obtained by adequate pressure directly into the scalp by means of a pin. Variations in ICP cause deformations in the cranial bone detected by the sensor bar. The device filters, amplifies, and scans the sensor signal and sends the data to a mobile device. The method is completely non-invasive and painless. In addition, it does not interfere with any routine monitoring.
Transcranial Doppler (TCD), because it is a technique for the study of CC influences on cerebrovascular hemodynamics and vice-versa, was used to associate the information obtained by the B4C sensor. The arteries of the right and left cerebral hemispheres and the brainstem were evaluated, with Doppler colored technique with low frequency probe (2MHz) every 1 mm of arterial extension, through the temporal, orbital, suboccipital, retromastoid and submandibular windows. Arteries analyzed: proximal segments of middle, anterior and posterior cerebral arteries, paraselar and supraclinoid carotid siphons, ophthalmic, vertebral and basilar. Hemodynamic parameters of interest were mean flow velocities, peak systolic velocities, final diastolic velocities and pulsatility indexes.
Data analysis methodology Data will be analyzed obtaining a correlation coefficient and predictive ability (ROC curve) acceptable between measurements performed with the noninvasive B4C technique compared to the clinical evaluation of the patient, TCD and other available physiological parameters. To meet the objectives and goals of the study, appropriate statistical techniques will be applied. All variables will be tested for normal distribution and appropriate statistical analysis. The normality of the distribution was verified by using the Kolmogorov-Smirnov or Shapiro-Wilk test. For the demographic and basic clinical variables, descriptive data analysis was used.
The automated Brain4care Analytics system will verify all collected data by the sensor. ICP pulse wave morphology parameters such as P2/P1 ratio (P2/P1 ratio and P1 and P2 classification: P1> P2 or P2> P1) and time to peak (TTP) were obtained and stored for analysis. The calculations are performed using the mean pulse of the ICP, calculated by identifying and extracting all ICP pulses, excluding possible artifacts. The mean pulse was used to calculate the amplitudes of the P1 and P2 peaks, which were obtained by detecting the highest point of these peaks and subtracting the base value of the ICP pulse. The P2/P1 ratio was calculated by dividing the amplitude of these two points. TTP was calculated by means of standardization of the mean pulse and temporal measurement from the beginning of the pulse to its highest point (greatest amplitude).
By TCD, the first signal and elevation of ICP and CC impairment is the elevation of the pulsatility index, calculated by the following formula: PI=Sv-Dv/Mv (Sv: systolic velocity, Dv: diastolic velocity and Mv: mean flow velocity), since excluded confounding factors such as distal stenosis of the cranial arteries, use of barbiturate in infusion pump, dehydration, sepsis, aortic or microvascular cerebral valve failure (microangiopathy) for example. Later, in situations of more severe intracranial hypertension, tissue tension is translated by TCD as sharper systolic peaks, observed by the suppression of the second systolic peak (sys2).
- Being tested
- Cerebral compliance and hemodynamics monitoring
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral compliance and hemodynamics monitoringDevice
Noninvasive devices are been used to assess cerebral circulation and compliance.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During critical care, around 15 days/patient
Secondary outcomes (1)
Calculate mortality in this population
Observe whether disturbances in cerebral compliance and hemodynamics assessed in this population is significantly associated with higher mortality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 May 2020
- Primary completion15 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Brasil, MD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429477
- Sponsor's protocol ID
- 31750820.1.0000.0068
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32104915Baig 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.
PubMed 32167747Needham 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.
PubMed 32346843Bridwell 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.
PubMed 32425321Niazkar 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.
PubMed 32483687Wu 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.
PubMed 32240762Delanghe 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.
PubMed 32220422Kochanek 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.
PubMed 30822776Frigieri 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.
PubMed 29492543Vilela 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.
PubMed 27165885Cabella 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.
PubMed 27165884Schaafsma 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.
PubMed 29920296Schaafsma 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.
PubMed 22579541
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebral Compliance and Hemodynamics in Severe COVID-19
- ClinicalTrials.gov ID
- NCT04429477
- Acronym / sponsor ID
- 31750820.1.0000.0068
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The gravity of the disease caused by the new coronavirus 2019 (COVID-19) is predominantly harbored in severe acute respiratory syndrome (SARS), often requiring ventilatory support. However, in some cases it has been observed that the involvement of this entity is not restrict to the respiratory tract, but also to the central nervous system (CNS), heart, kidneys, intestines and testicles, or even the cross-response of the immune system with potential for Guillain-Barre and Miller-Fisher syndromes. It is not yet clear whether acute respiratory failure in patients with COVID-19 is due exclusively to pulmonary invasion or because of concurrent CNS disorders, however, as many of these patients have neurological symptoms such as headache, anosmia, paresthesia, nausea, vomiting and consciousness level alterations during the early stages of the disease, the hypothesis of this entity in promoting cerebral compliance (CC) impairment directly (i.e. encephalitis, edema or focal ischemia) or indirectly (i.e. hypoxic distress and linkage to angiotensin-converting enzyme) becomes suitable.
Intracranial pressure (ICP) monitoring is relevant in several CNS diseases with risk for critical intracranial hypertension (ICH)(10). Still, this parameter is considered in specific situations, limiting its use in neurocritical settings, especially because of the invasive nature of the monitoring techniques available. ICH has potential to compromise CC and, consequently, promote brain tissue damage. Regarding COVID-19, unless a mass effect structural damage documented by encephalic imaging is evident, there is no justification to perform a trepanation to implant an ICP monitor, hence, noninvasive techniques such as transcranial Doppler by means of cerebral hemodynamics evaluation and the novel cranial pulse detector (B4C), by means of the quantitative evaluation of the ICP curves, may play a role in this scenario.
The purpose of the present study was to evaluate CC in a set of COVID-19 patients, since implementation until withdrawal of respiratory support in ICU, to evaluate the potential persistence of CC impairment in this population. Prolonged CC impairment observation may aid decision making and targeted therapy in this population. Study design A single center, observational and prospective research was conducted including consecutive subjects in intensive care units (ICU) of the Hospital das Clínicas, São Paulo University, Brazil, with approval of local ethics committee. Our inclusion criteria regarded patients with SARS for COVID-19, under ventilatory support of any age and gender. Exclusion criteria comprehended 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. The study protocol followed the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement.
Eligible subjects are selected by the ICU team (SF, BT, EB and LMSM) 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 are repeated once again during the first three days after extubating, 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 was quantified using the simplified acute physiologic score (SAPS 3).
CC monitoring techniques Cerebral compliance was evaluated noninvasively by the cranial deformation method developed by brain4care (B4C). The B4C sensor consists of a support for a sensor bar for the detection of local cranial bone deformations adapted with deformation sensors. The detection of these deformations is obtained by a cantilever bar modeled by finite element calculations. For this bar, voltage meters are attached for deformation detection. Noninvasive contact with the skull is obtained by adequate pressure directly into the scalp by means of a pin. Variations in ICP cause deformations in the cranial bone detected by the sensor bar. The device filters, amplifies, and scans the sensor signal and sends the data to a mobile device. The method is completely non-invasive and painless. In addition, it does not interfere with any routine monitoring.
Transcranial Doppler (TCD), because it is a technique for the study of CC influences on cerebrovascular hemodynamics and vice-versa, was used to associate the information obtained by the B4C sensor. The arteries of the right and left cerebral hemispheres and the brainstem were evaluated, with Doppler colored technique with low frequency probe (2MHz) every 1 mm of arterial extension, through the temporal, orbital, suboccipital, retromastoid and submandibular windows. Arteries analyzed: proximal segments of middle, anterior and posterior cerebral arteries, paraselar and supraclinoid carotid siphons, ophthalmic, vertebral and basilar. Hemodynamic parameters of interest were mean flow velocities, peak systolic velocities, final diastolic velocities and pulsatility indexes.
Data analysis methodology Data will be analyzed obtaining a correlation coefficient and predictive ability (ROC curve) acceptable between measurements performed with the noninvasive B4C technique compared to the clinical evaluation of the patient, TCD and other available physiological parameters. To meet the objectives and goals of the study, appropriate statistical techniques will be applied. All variables will be tested for normal distribution and appropriate statistical analysis. The normality of the distribution was verified by using the Kolmogorov-Smirnov or Shapiro-Wilk test. For the demographic and basic clinical variables, descriptive data analysis was used.
The automated Brain4care Analytics system will verify all collected data by the sensor. ICP pulse wave morphology parameters such as P2/P1 ratio (P2/P1 ratio and P1 and P2 classification: P1> P2 or P2> P1) and time to peak (TTP) were obtained and stored for analysis. The calculations are performed using the mean pulse of the ICP, calculated by identifying and extracting all ICP pulses, excluding possible artifacts. The mean pulse was used to calculate the amplitudes of the P1 and P2 peaks, which were obtained by detecting the highest point of these peaks and subtracting the base value of the ICP pulse. The P2/P1 ratio was calculated by dividing the amplitude of these two points. TTP was calculated by means of standardization of the mean pulse and temporal measurement from the beginning of the pulse to its highest point (greatest amplitude).
By TCD, the first signal and elevation of ICP and CC impairment is the elevation of the pulsatility index, calculated by the following formula: PI=Sv-Dv/Mv (Sv: systolic velocity, Dv: diastolic velocity and Mv: mean flow velocity), since excluded confounding factors such as distal stenosis of the cranial arteries, use of barbiturate in infusion pump, dehydration, sepsis, aortic or microvascular cerebral valve failure (microangiopathy) for example. Later, in situations of more severe intracranial hypertension, tissue tension is translated by TCD as sharper systolic peaks, observed by the suppression of the second systolic peak (sys2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with SARS for COVID-19, under ventilatory support of any age and gender
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral compliance and hemodynamics monitoringNoninvasive devices are been used to assess cerebral circulation and compliance. | Device | – |
Primary outcome
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.
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.
1 secondary outcome
Calculate mortality in this population
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Background: PubMed 32104915Li 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.
- Background: PubMed 32167747Baig 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.
- Background: PubMed 32346843Needham 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.
- Background: PubMed 32425321Bridwell 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.
- Background: PubMed 32483687Niazkar 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.
- Background: PubMed 32240762Wu 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.
- Background: PubMed 32220422Delanghe 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.
- Background: PubMed 30822776Kochanek 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.
- Background: PubMed 29492543Frigieri 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.
- Background: PubMed 27165885Vilela 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.
- Background: PubMed 27165884Cabella 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.
- Background: PubMed 29920296Schaafsma 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.
- Individual participant dataSharing planned: No
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Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
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Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
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Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension and Cerebral Circulatory Failure, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cerebral compliance impairment by the B4C sensor (time frame: During critical care, around 15 days/patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04429477, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.