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

• Conditions: ARDS, Human; Covid19

• Registration Number: NCT04692129
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study Start: 2020-05-29
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)	20 minutes	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

Trial Locations

Locations (6)

Hospital de Clñinicas da UNICAMP; 🇧🇷 Campinas, Sao Paulo, Brazil

Hospital General de México; 🇲🇽 México, Mexico

Parc Taulí Hospital Universitari; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Parc Salut Mar; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain