Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

NCT04905875 | Unknown

• 1 other identifier: 22/21
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Description of the over-time variation of clinical variables during prone positioning

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Prone Position PROCEDURE

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.

Critically ill patients with COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Laboratory-confirmed COVID-19 infection
• Prone positioning in patients admitted to ICU undergoing invasive Mechanical Ventilation

You may not qualify if:

• Bedsides contraindications to the Prone Positioning and patients in PP but undergoing Non- invasive ventilation should be excluded.

Sponsors & Collaborators

• St. Bortolo Hospital: lead

Study Sites (1)

Silvia De Rosa

Vicenza, 36100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 31789984 RESULT

• 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.

  PMID: 32414420 RESULT

• 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.

  PMID: 32569585 RESULT

• De Rosa S, Sella N, Rezoagli E, Lorenzoni G, Gregori D, Bellani G, Foti G, Pettenuzzo T, Baratto F, Fullin G, Papaccio F, Peta M, Poole D, Toffoletto F, Maggiore SM, Navalesi P; SIAARTI Study Group. The PROVENT-C19 registry: A study protocol for international multicenter SIAARTI registry on the use of prone positioning in mechanically ventilated patients with COVID-19 ARDS. PLoS One. 2022 Dec 30;17(12):e0276261. doi: 10.1371/journal.pone.0276261. eCollection 2022.

  PMID: 36584022 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Silvia De Rosa

  Ospedale San Bortolo di Vicenza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia De Rosa, MD

CONTACT

+393933098583; derosa.silvia@ymail.com

Paolo Navalesi, MD

CONTACT

pnavalesi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 28, 2021
• Study Start: December 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)