Covid19PRONECOVID19NCT04692129
Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients
An observational study of Covid19 and ARDS, Human, run by Corporacion Parc Tauli at 6 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, ARDS, Human
- How many people
- 100 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 29 May 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patients with severe hypoxemia, under mechanical ventilation, and requiring prone positioning as a rescue therapy for hypoxemia management
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona
Pedro Castro, pcastro@clinic.cat
- Recruiting
Hospital Parc Salut Mar
Barcelona
Judith Marin Corral, MD, PhD, jmarin@imim.es
Clara Vila
- Recruiting
Hospital Vall d'Hebron
Barcelona
Ricard Ferrer, r.ferrer@vhebron.net
Marina García de Acilu
- Recruiting
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208
Jaume Mesquida, jmesquida@tauli.cat
Alba Caballer
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clñinicas da UNICAMP
Campinas, São Paulo
Rickson Coelho Mesquita, rickson@ifi.unicamp.br
Rodrigo Forti
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México
México
Argelia Pérez Pacheco, argeliapp@ciencias.unam.mx
About this study
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
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
Read the 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.
- Conditions
- Covid19, ARDS, Human
- Keywords
- COVID-19, Tissue oxygenation, ARDS, Prone position
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue oxygenation (StO2)
Tissue oxygenation is measured as percent of oxyhemoglobin over total hemoglobin content in the sensed area (skeletal muscle)
Measured: 20 minutes
Change in local hemoglobin content (THC)
THC is measured as microMols
Measured: 20 minutes
Secondary outcomes (1)
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start29 May 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO), Centre de Recerca Matemàtica, Institute of Physics University of Campinas
- Responsible party
- Principal investigator, Jaume Mesquida, Corporacion Parc Tauli
- Investigators
- Jaume Mesquida, Principal investigator, Parc Taulí Hospital Universitari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692129
- Sponsor's protocol ID
- 2020/591
- Acronym
- PRONECOVID19
- Status last verified
- Jul 2022
- First submitted
- 30 Dec 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04692129
- Acronym / sponsor ID
- PRONECOVID19 / 2020/591
- Conditions
- Covid19, ARDS, Human
- Keywords
- COVID-19, Tissue oxygenation, ARDS, Prone position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO), Centre de Recerca Matemàtica, Institute of Physics University of Campinas
- Study start
- 29 May 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients with severe hypoxemia, under mechanical ventilation, and requiring prone positioning as a rescue therapy for hypoxemia management
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in tissue oxygenation (StO2)
Time frame: 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)
Time frame: 20 minutes
THC is measured as microMols
1 secondary outcome
Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaume Mesquida principal investigator
Parc Taulí Hospital Universitari
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and ARDS, Human, run by Corporacion Parc Tauli at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Brazil, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaume Mesquida, MD, PhD (+34 937231010 ext. 21155, jmesquida@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tissue oxygenation (StO2) (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.