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

Covid19 Clinical Trial

— PRONECOVID19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692129
• Other study ID #: 2020/591
• Status: Recruiting
• Start date: May 29, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: Corporacion Parc Tauli
• Contact: Jaume Mesquida, MD, PhD
• Phone: +34 937231010
• Email: jmesquida[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• COVID-19
• Covid19
• Respiratory Distress Syndrome

Locations

Country	Name	City	State
Brazil	Hospital de Clñinicas da UNICAMP	Campinas	Sao Paulo
Mexico	Hospital General de México	México
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Parc Salut Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Parc Taulí Hospital Universitari	Sabadell	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Centre de Recerca Matemàtica, Institut de Ciències Fotòniques (ICFO), Institute of Physics University of Campinas

Countries where clinical trial is conducted

Brazil,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in local hemoglobin content (THC)	THC is measured as microMols	20 minutes
Secondary	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