Non-Invasive Intracranial Pressure in COVID-19 Individuals

Summary

The use of non-invasive intracranial pressure monitoring, including intracranial pressure pulse morphology in patients with COVID-19, could calculate possible components associated with the presence of neurological symptoms in these patients, in addition to being a tool with the potential to monitor the repercussion of MV at cerebral compliance patient patients. In addition, it is likely that patients with COVID-19 also have cerebral embolization more frequently than healthy patients, which is justified by transcranial doppler ultrasound assessment. The aim of the study is to monitor this brain pressure using a non-invasive method of monitoring, with a helmet-like system in place, for 1 hour for 7 consecutive days. There will be no associated invasive procedure of any kind. Monitoring will be done by the criteria themselves, no place where the patient and the mandatory volunteer. Another objective is to capture signs of microembolisms (small strokes that have not yet manifested) by performing a doppler ultrasound on the head with a helmet also for 1 hour, in a single evaluation.

The study population will include inpatients with COVID-19 infection. The control group will be in patients who do not have Covid-19. The control group will consist of people with similar characteristics and who have not recovered. Patients who meet the inclusion criteria incorporated into the monitoring with a non-invasive intracranial pressure device for 1 hour during hospitalization (Brain4Care® device approved by ANVISA), being monitored for up to seven days, in addition to monitoring for 1 hour with a transcranial doppler ultrasound helmet DWL® in a single assessment. There will be no invasive procedures or other equipment used without due knowledge by Organs competent bodies. It does not collect collection or retention of any biological material.

Conditions

• Intracranial Pressure

Interventions

DEVICE

The ICP monitoring will be performed in a non-invasive method developed by Brain4Care

The ICP monitoring will be performed in a non-invasive way through the cranial deformation method developed by Brain4Care Inc. The selected patients will be monitored until 1h/day for 7 sequential days or even discharge. The clinical outcomes such as ventilatory status will be noted (if the subject is under oxygen supplementation, using non-invasive mechanical ventilation or intubated), the ventilatory parameters during the monitorization will be analyzed in the intubated group (or those from a non-intubated group who was intubated during the seven days of hospitalization) including IFO2, CV, PEEP, driving pressure, and pressure plate as well as ventilatory asynchronies. Some changes in ventilatory parameters during monitorization will be noted. These procedures will be applied to all groups, excepted to the healthy group. This last group will be monitored only once for 30 minutes at the Federal University of São Carlos (UFSCar).

Sponsors & Collaborators

• Sens4care

  collaborator INDUSTRY

• Federal University of São Paulo

  lead OTHER

Principal Investigators

• GISELE GS SILVA, SAMPAIO · Uf SAO PAULO

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-30

Primary Completion

2021-07-15

Completion

2021-12-15

FDA Device

Yes

Countries

• Brazil

Study Locations