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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Recruiting

CT.gov ID

NCT04692129

Collaborator

Institut de Ciències Fotòniques (ICFO) (Other), Centre de Recerca Matemàtica (Other), Institute of Physics University of Campinas (Other)

100

Enrollment

Locations

29.1

Anticipated Duration (Months)

16.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 29, 2020

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Outcome Measures

Primary Outcome Measures

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)
Change in local hemoglobin content (THC) [20 minutes]
THC is measured as microMols

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clñinicas da UNICAMP	Campinas	Sao Paulo	Brazil
2	Hospital General de México	México		Mexico
3	Parc Taulí Hospital Universitari	Sabadell	Barcelona	Spain	08208
4	Hospital Clínic i Provincial de Barcelona	Barcelona		Spain
5	Hospital Parc Salut Mar	Barcelona		Spain
6	Hospital Vall d'Hebron	Barcelona		Spain