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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04692129

Acronym

PRONECOVID19

Enrollment

100

Registered

2020-12-31

Start date

2020-05-29

Completion date

2022-10-31

Last updated

2022-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, Covid19

Keywords

COVID-19, Tissue oxygenation, ARDS, Prone position

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Brazil, Mexico, Spain

Contacts

Primary ContactJaume Mesquida, MD, PhD

jmesquida@tauli.cat+34 937231010

Outcome results