Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

NCT ID: NCT04905875

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-05-01

Brief Summary

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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

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Conditions

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COVID-19 Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Prone Position

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Bortolo Hospital

OTHER

Sponsor Role lead

Responsible Party

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Silvia De Rosa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvia De Rosa

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Bortolo di Vicenza

Locations

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Silvia De Rosa

Vicenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Silvia De Rosa, MD

Role: CONTACT

+393933098583

Paolo Navalesi, MD

Role: CONTACT

Facility Contacts

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Silvia De Rosa

Role: primary

3933098583

References

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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.

Reference Type RESULT
PMID: 31789984 (View on PubMed)

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.

Reference Type RESULT
PMID: 32414420 (View on PubMed)

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.

Reference Type RESULT
PMID: 32569585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36584022 (View on PubMed)

Related Links

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Other Identifiers

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22/21

Identifier Type: -

Identifier Source: org_study_id

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