Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04689477
Acronym
HEMOCOVID19
Enrollment
612
Registered
2020-12-30
Start date
2020-05-25
Completion date
2022-10-31
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Endothelial Function

Keywords

COVID-19

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.

Interventions

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.

Sponsors

Institut de Ciències Fotòniques (ICFO)
CollaboratorUNKNOWN
Centre de Recerca Matemàtica
CollaboratorUNKNOWN
Institute of Physics University of Campinas
CollaboratorUNKNOWN
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28 daysMortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19

Countries

Brazil, Mexico, Spain, United States

Contacts

Primary ContactJaume Mesquida, MD, PhD
jmesquida@tauli.cat+34 937231010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026