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
1 other identifier
observational
100
3 countries
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2020
CompletedFirst Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJuly 28, 2022
July 1, 2022
2.4 years
December 30, 2020
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)
20 minutes
Eligibility Criteria
COVID-19 patients with severe hypoxemia, under mechanical ventilation, and requiring prone positioning as a rescue therapy for hypoxemia management
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corporacion Parc Taulilead
- Institut de Ciències Fotòniques (ICFO)collaborator
- Centre de Recerca Matemàticacollaborator
- Institute of Physics University of Campinascollaborator
Study Sites (6)
Hospital de Clñinicas da UNICAMP
Campinas, São Paulo, Brazil
Hospital General de México
México, Mexico
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Parc Salut Mar
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaume Mesquida
Parc Taulí Hospital Universitari
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 30, 2020
First Posted
December 31, 2020
Study Start
May 29, 2020
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
July 28, 2022
Record last verified: 2022-07