Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

COVID-19 Pneumonia Clinical Trial

— PROVENT-C19  

Official title:

Prone Positioning for Invasively Ventilated Patients With COVID-19: an Interactive, Web-based, Multicenter, Observational Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905875
• Other study ID #: 22/21
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2021
• Source: St. Bortolo Hospital
• Contact: Silvia De Rosa, MD
• Phone: +393933098583
• Email: derosa.silvia[@]ymail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Italy	Silvia De Rosa	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
St. Bortolo Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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 acu — View Citation

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Related Info