NCT04689477

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 612 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Endothelial Function

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-05-25
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-12-30
• Last updated: 2022-08-01

Locations

8 sites across 4 countries: United States, Brazil, Mexico, Spain

Regulatory

• FDA-regulated device study