Clinical trial NCT04692129: Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
ARDS, Human
Keywords: COVID-19
Tissue oxygenation
ARDS
Prone position
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Institut de Ciències Fotòniques (ICFO)
name: Centre de Recerca Matemàtica
name: Institute of Physics University of Campinas
First posted: 2020-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 patients with severe hypoxemia, under mechanical ventilation, and requiring prone positioning as a rescue therapy for hypoxemia management

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.

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

Primary outcomes:
measure: Change in tissue oxygenation (StO2)
timeFrame: 20 minutes
measure: Change in local hemoglobin content (THC)
timeFrame: 20 minutes
Secondary outcomes:
measure: Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital de Clñinicas da UNICAMP
state: Sao Paulo
city: México
country: Mexico
facility: Hospital General de México
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Parc Salut Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Parc Taulí Hospital Universitari
name: Jaume Mesquida
role: PRINCIPAL_INVESTIGATOR
References: