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Clinical Trials/NCT04692129
NCT04692129
Unknown
Not Applicable

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

Corporacion Parc Tauli6 sites in 3 countries100 target enrollmentMay 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Corporacion Parc Tauli
Enrollment
100
Locations
6
Primary Endpoint
Change in local hemoglobin content (THC)
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2020
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Jaume Mesquida

Principal Investigator

Corporacion Parc Tauli

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in local hemoglobin content (THC)

Time Frame: 20 minutes

THC is measured as microMols

Change in tissue oxygenation (StO2)

Time Frame: 20 minutes

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

Secondary Outcomes

  • Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)(20 minutes)

Study Sites (6)

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