Status:
COMPLETED
Non-Invasive Intracranial Pressure in COVID-19 Individuals
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Sens4care
Conditions:
Intracranial Pressure
Eligibility:
All Genders
18+ years
Brief 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 o...
Detailed Description
INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) is an infectious disease transmitted one person to another mainly from cough and sneeze aerosols as well as from contaminated surfaces. The most c...
Eligibility Criteria
Inclusion
- For COVID-19 group:
- Men and women (not pregnant) Older than 18 years old Diagnosis of COVID-19 confirmed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) Subjects intubated or non-intubated Time between admission and study inclusion ≤ 72h For intubated group time between IUC admission and study inclusion ≤ 72h Time between onset symptoms and study inclusion ≤ 14 days No neurological acute disease No cutaneous injury in the head to impossibility the ICP monitoring ICF signed by the participant or his/her legal representative\*
- No cutaneous injury in the head to impossibility the monitoring with the transcranial doppler helmet Patients who have not been submitted to decompressive craniectomy previously. Subjects intubated or non-intubated For intubated group time between IUC admission and study inclusion ≤ 72h Time between admission and study inclusion ≤ 72h Time between onset symptoms and study inclusion ≤14 days No neurological acute disease
- For Controls Group:
- Men and women (not pregnant) Older than 18 years old No cutaneous injury in the head to impossibility the ICP monitoring • For intubated group: ICF signed by the participant or his/her legal representative\* Intubated patients for others causes than COVID-19 or neurological diseases IUC admission and study inclusion ≤ 72h No symptoms of COVID-19 on the last 15 days
- • For healthy group: No previous neurological disease No chronic disease as Diabetes Mellitus Type 2, Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, hypertension or Chronic Kidney Disease (CKD)
- No cutaneous injury in the head to impossibility the monitoring with the transcranial doppler helmet Patients who have not been submitted to decompressive craniectomy previously.
- IUC admission and study inclusion ≤ 72h No neurological diseases
Exclusion
- It will be excluded those who asked to stop their participation, and those with problems in acquiring ICP data.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04861402
Start Date
April 30 2020
End Date
December 15 2021
Last Update
September 15 2025
Active Locations (1)
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1
Hospital São Paulo
São Paulo, São Paulo, Brazil, 05409-003