Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry (PROVENT-C19)
May 27, 2021 updated by: Silvia De Rosa, St. Bortolo Hospital
Prone Positioning for Invasively Ventilated Patients With COVID-19: an Interactive, Web-based, Multicenter, Observational Registry
SARS-CoV-2 infection is characterized mainly by moderate/severe pneumonia associated with progressive endothelial damage and coagulopathy.
Acute respiratory failure among COVID-19 occurs in 42% of patients with COVID-19 pneumonia, and 61-81% of patients requiring intensive care .
Among the suggested treatments for the management of ARDS patients, prone position (PP) can be used as an adjuvant therapy for improving ventilation in these patients, as recommended in the Surviving Sepsis Campaign COVID-19 guidelines.
Nevertheless, no data is currently available on application and feasibility of PP in invasively ventilated patients with COVID-19 on their outcomes.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paolo Navalesi, MD
- Email: pnavalesi@gmail.com
Study Locations
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Vicenza, Italy, 36100
- Recruiting
- Silvia De Rosa
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Contact:
- Silvia De Rosa
- Phone Number: 3933098583
- Email: derosa.silvia@ymail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All critically ill patients undergoing PP in the enrolling centers will be retrospectively and prospectively observed.
It should be underlined that the lack of consensus concerning the timing and duration of PP leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep web-based, multicenter, observational registry" inclusion criteria as wide as possible so as to obtain a real picture of the clinical practice worldwide.
Description
Inclusion Criteria:
- Laboratory-confirmed COVID-19 infection
- Prone positioning in patients admitted to ICU undergoing invasive Mechanical Ventilation
Exclusion Criteria:
- Bedsides contraindications to the Prone Positioning and patients in PP but undergoing Non- invasive ventilation should be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Critically ill patients with COVID-19
n centres that obtained IRB approval for this prospective study, all critically ill adult patients (>18yrs) undergoing PP - that are homogeneous in terms of both clinical and treatment characteristics - will be prospectively observed.
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Every center will prescribe PP in accordance with local practice and local levels of expertise.
No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study.
Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of the subpopulation of critically ill patients that most benefits from prone positioning their intermediate surrogate endpoints. Identification of the subpopulation of critically ill patients with COVID-19 that most benefits from
Time Frame: through study completion, an average of 1 year
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This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome.
In particular baseline variables statistically associated through multivariable regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Description of the over-time variation of clinical variables during prone positioning
Time Frame: through study completion, an average of 1 year
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this over-time variation will be expressed, for each variable, as a percentage variation compared with the baseline value (at the prone position initiation).static
compliance of the respiratoty system will be assessed
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia De Rosa, Ospedale San Bortolo di Vicenza
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lucchini A, Bambi S, Mattiussi E, Elli S, Villa L, Bondi H, Rona R, Fumagalli R, Foti G. Prone Position in Acute Respiratory Distress Syndrome Patients: A Retrospective Analysis of Complications. Dimens Crit Care Nurs. 2020 Jan/Feb;39(1):39-46. doi: 10.1097/DCC.0000000000000393.
- Carsetti A, Damia Paciarini A, Marini B, Pantanetti S, Adrario E, Donati A. Prolonged prone position ventilation for SARS-CoV-2 patients is feasible and effective. Crit Care. 2020 May 15;24(1):225. doi: 10.1186/s13054-020-02956-w. No abstract available.
- Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
May 24, 2021
First Submitted That Met QC Criteria
May 26, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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