Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry (PROVENT-C19)

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

• Status: Recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Procedure: Prone Position

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Paolo Navalesi, MD; Email: pnavalesi@gmail.com

Study Locations

• Italy
  • Vicenza, Italy, 36100
    • Recruiting
    • Silvia De Rosa
    • Contact: Silvia De Rosa; Phone Number: 3933098583; Email: derosa.silvia@ymail.com

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Prone Position; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the over-time variation of clinical variables during prone positioning	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: St. Bortolo Hospital
• Investigators: Principal Investigator: Silvia De Rosa, Ospedale San Bortolo di Vicenza

Publications and helpful links

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

• Related Info

Study record dates

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: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• 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