Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
NCT ID: NCT04689477
Last Updated: 2022-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
612 participants
OBSERVATIONAL
2020-05-25
2022-10-31
Brief Summary
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Detailed Description
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Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COVID-19
Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia.
Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Control
Healthy subjects
Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Non-COVID critically ill patients
Non-COVID critically ill patients admitted to the ICU.
Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Interventions
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Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Eligibility Criteria
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Inclusion Criteria
* Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.
Exclusion Criteria
* Raynaud's syndrome
* Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
* Deep venous thrombosis in the upper limbs
18 Years
ALL
Yes
Sponsors
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Institut de Ciències Fotòniques (ICFO)
UNKNOWN
Centre de Recerca Matemàtica
UNKNOWN
Institute of Physics University of Campinas
UNKNOWN
Corporacion Parc Tauli
OTHER
Responsible Party
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Jaume Mesquida
MD, PhD
Principal Investigators
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Jaume Mesquida, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Corporacion Parc Tauli
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Hospital de Clinicas da UNICAMP
Campinas, São Paulo, Brazil
Hospital Das Clínicas University of Sao Paulo Medical School
São Paulo, , Brazil
Hospital General de México
México, , Mexico
Institut d'Investigació i Innovació Parc Taulí
Sabadell, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital Parc Salut Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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David Busch
Role: primary
Leandro U Taniguchi
Role: primary
References
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Mesquida J, Caballer A, Cortese L, Vila C, Karadeniz U, Pagliazzi M, Zanoletti M, Pacheco AP, Castro P, Garcia-de-Acilu M, Mesquita RC, Busch DR, Durduran T; HEMOCOVID-19 Consortium. Peripheral microcirculatory alterations are associated with the severity of acute respiratory distress syndrome in COVID-19 patients admitted to intermediate respiratory and intensive care units. Crit Care. 2021 Nov 8;25(1):381. doi: 10.1186/s13054-021-03803-2.
Related Links
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Related Info
Other Identifiers
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2020/579
Identifier Type: -
Identifier Source: org_study_id
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