Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients

Corporacion Parc Tauli100 enrolled

Overview

The purpose of this study is to monitor short-term changes in tissue oxygen saturation and local blood flow as results of changing from supine to prone position in ARDS COVID-19 patients

After obtaining consent to participate in the study, the subjects included in the study will undergo a baseline 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. Tissue oxygenation measurements will be performed in supine position, immediately before changing to prone positioning, and repeated after 20 minutes of stabilization, once in prone position.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Covid19 ARDS, Human

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * COVID-19 patients admitted in the ICU receiving invasive mechanical ventilation and requiring prone positioning for severe hypoxemia management, as decided by the medical team Exclusion Criteria: * Severe peripheral vasculopathy * Raynaud's syndrome * Skin lesions/trauma in upper limbs interfering the placement of the NIRS probe and/or the occlusion tourniquet * Deep venous thrombosis in the upper limbs

Locations (6)

Hospital de Clñinicas da UNICAMP

Campinas, São Paulo, Brazil

RECRUITING

Hospital General de México

México, Mexico

RECRUITING

Parc Taulí Hospital Universitari

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Change in tissue oxygenation (StO2)

Tissue oxygenation is measured as percent of oxyhemoglobin over total hemoglobin content in the sensed area (skeletal muscle)

Time frame: 20 minutes

Change in local hemoglobin content (THC)

THC is measured as microMols

Time frame: 20 minutes

Secondary Outcomes

Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)

Arterial oxygenation (SaO2) is obtained from blood gas analysis, from an arterial blood sample, while StO2 is derived from the sensed tissue, by means of NIRS/DCS technology

Time frame: 20 minutes

Central Contacts

Jaume Mesquida, MD, PhD

CONTACT

+34 937231010 jmesquida@tauli.cat

Data from ClinicalTrials.gov

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