Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

Corporacion Parc Tauli612 enrolled

Overview

The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.

After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient. Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.

Study Type

OBSERVATIONAL

Enrollment

612

Conditions

COVID-19 Endothelial Function

Interventions

Vascular occlusion testDEVICE

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Recent diagnosis of SARS-CoV2 infection * Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload. Exclusion Criteria: * Severe peripheral vasculopathy * 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

Locations (8)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

RECRUITING

Hospital de Clinicas da UNICAMP

Campinas, São Paulo, Brazil

RECRUITING

Hospital Das Clínicas University of Sao Paulo Medical School

São Paulo, Brazil

Outcomes

Primary Outcomes

28-day mortality

Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19

Time frame: 28 days

Central Contacts

Jaume Mesquida, MD, PhD

CONTACT

+34 937231010 jmesquida@tauli.cat

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.