Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

• Conditions: COVID-19 Pneumonia
• Interventions: Procedure: Prone Position

• Registration Number: NCT04905875
• Lead Sponsor: St. Bortolo Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-06-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients with COVID-19	Prone Position	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.

Primary Outcome Measures

Name	Time	Method
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	through study completion, an average of 1 year	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Silvia De Rosa; 🇮🇹 Vicenza, Italy