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Clinical Trials/NCT04689477
NCT04689477
Unknown
Not Applicable

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

Corporacion Parc Tauli8 sites in 4 countries612 target enrollmentMay 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Corporacion Parc Tauli
Enrollment
612
Locations
8
Primary Endpoint
28-day mortality
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2020
End Date
October 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Jaume Mesquida

MD, PhD

Corporacion Parc Tauli

Eligibility Criteria

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

Outcomes

Primary Outcomes

28-day mortality

Time Frame: 28 days

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

Study Sites (8)

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