Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients (PRONECOVID19)

Short-term Effects of Prone Positioning on Tissue Oxygen Saturation, Measured by Near-infrared Spectroscopy, in COVID-19 Patients With Acute Respiratory Distress Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Covid19; ARDS, Human

Detailed Description

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 (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jaume Mesquida, MD, PhD; Phone Number: 21155 +34 937231010; Email: jmesquida@tauli.cat

Study Locations

• Brazil
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil
      • Recruiting
      • Hospital de Clñinicas da UNICAMP
      • Contact: Rickson Coelho Mesquita; Email: rickson@ifi.unicamp.br
      • Sub-Investigator: Rodrigo Forti
• Mexico
  • México, Mexico
    • Recruiting
    • Hospital General de Mexico
    • Contact: Argelia Pérez Pacheco; Email: argeliapp@ciencias.unam.mx
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona
    • Contact: Pedro Castro; Email: pcastro@clinic.cat
  • Barcelona, Spain
    • Recruiting
    • Hospital Vall d'Hebron
    • Contact: Ricard Ferrer; Email: r.ferrer@vhebron.net
    • Sub-Investigator: Marina García de Acilu
  • Barcelona, Spain
    • Recruiting
    • Hospital Parc Salut Mar
    • Sub-Investigator: Clara Vila
    • Contact: Judith Marin Corral, MD, PhD; Email: jmarin@imim.es
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Parc Tauli Hospital Universitari
      • Sub-Investigator: Alba Caballer
      • Sub-Investigator: Cristina Espinal
      • Contact: Jaume Mesquida; Email: jmesquida@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COVID-19 patients with severe hypoxemia, under mechanical ventilation, and requiring prone positioning as a rescue therapy for hypoxemia management

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tissue oxygenation (StO2)	Tissue oxygenation is measured as percent of oxyhemoglobin over total hemoglobin content in the sensed area (skeletal muscle)	20 minutes
Change in local hemoglobin content (THC)	THC is measured as microMols	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	20 minutes

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Institut de Ciències Fotòniques (ICFO); Centre de Recerca Matemàtica; Institute of Physics University of Campinas
• Investigators: Principal Investigator: Jaume Mesquida, Parc Tauli Hospital Universitari

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Prone position; Tissue oxygenation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Distress Syndrome
• Other Study ID Numbers: 2020/591

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No