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

NCT ID: NCT04692129

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-29

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Covid19 ARDS, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Ciències Fotòniques (ICFO)

UNKNOWN

Sponsor Role collaborator

Centre de Recerca Matemàtica

UNKNOWN

Sponsor Role collaborator

Institute of Physics University of Campinas

UNKNOWN

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Jaume Mesquida

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaume Mesquida

Role: PRINCIPAL_INVESTIGATOR

Parc Taulí Hospital Universitari

Locations

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Hospital de Clñinicas da UNICAMP

Campinas, São Paulo, Brazil

Site Status RECRUITING

Hospital General de México

México, , Mexico

Site Status RECRUITING

Parc Taulí Hospital Universitari

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Parc Salut Mar

Barcelona, , Spain

Site Status RECRUITING

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Brazil Mexico Spain

Central Contacts

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Jaume Mesquida, MD, PhD

Role: CONTACT

+34 937231010 ext. 21155

Facility Contacts

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Rickson Coelho Mesquita

Role: primary

Argelia Pérez Pacheco

Role: primary

Jaume Mesquida

Role: primary

Pedro Castro

Role: primary

Judith Marin Corral, MD, PhD

Role: primary

Ricard Ferrer

Role: primary

Other Identifiers

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2020/591

Identifier Type: -

Identifier Source: org_study_id

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