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

• Conditions: Endothelial Function; COVID-19
• Interventions: Device: Vascular occlusion test

• Registration Number: NCT04689477
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-05-25
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-08-01
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 612

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	Vascular occlusion test	Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia.
Control	Vascular occlusion test	Healthy subjects
Non-COVID critically ill patients	Vascular occlusion test	Non-COVID critically ill patients admitted to the ICU.

Primary Outcome Measures

Name	Time	Method
28-day mortality	28 days	Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19

Trial Locations

Locations (8)

Hospital de Clinicas da UNICAMP; 🇧🇷 Campinas, Sao Paulo, Brazil

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Das Clínicas University of Sao Paulo Medical School; 🇧🇷 Sao Paulo, Brazil

Institut d'Investigació i Innovació Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Parc Salut Mar; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital General de México; 🇲🇽 México, Mexico