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Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04905875
Acronym
PROVENT-C19
Enrollment
1000
Registered
2021-05-28
Start date
2020-12-01
Completion date
2022-05-01
Last updated
2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

Brief 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.

Interventions

PROCEDUREProne 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.

Sponsors

St. Bortolo Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
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 fromthrough study completion, an average of 1 yearThis 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

Secondary

MeasureTime frameDescription
Description of the over-time variation of clinical variables during prone positioningthrough study completion, an average of 1 yearthis 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

Countries

Italy

Contacts

Primary ContactSilvia De Rosa, MD
derosa.silvia@ymail.com+393933098583
Backup ContactPaolo Navalesi, MD
pnavalesi@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026