The Prone Position in Covid-19 Affected Patients (PRON-COVID)

April 28, 2022 updated by: University of Milano Bicocca

Study of the Feasibility and Usefulness of the Prone Position in Patients With Respiratory Distress From Covid-19 Not Intubated, in Spontaneous Breath in Oxygen Therapy or Cpap

The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

It has been shown that the prone position (PP) during mechanical ventilation (VM) in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality.

The reduced mortality, however, is not only caused by an increase in oxygen, but also by the ability of the PP to reduce the damage associated with mechanical ventilation (VILI).

Studies show that the benefits of PP are also present in non-intubated patients; the PP prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).

Moreover, a reduction in the need for intubation and therefore hospitalization in the ICU would be particularly useful in a context of great health emergency with limited resources.

The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.

STUDY DESIGN:

This is a monocentric study that will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP.

Sample size (n. Patients): 56

The duration of enrollment is estimated in 1 month. Patients will be monitored until discharged from the hospital. The overall duration of the study is estimated to be 1 year (including enrollment, follow up and data analysis).

The patient will be enrolled in the study when consent is obtained. The following data will be collected:

  • Patient registration
  • Demographic and anthropometric data
  • Comorbidity and lifestyle habits
  • Hospitalization data
  • Blood chemistry tests
  • Ventilation parameters

After 10 minutes and at the end of pronation, the feasibility of pronation and ventilation parameters will also be assessed.

STATISTICAL ANALYSIS:

Clinical data relating to enrolled patients will be analysed by means of descriptive statistics on continuous quantitative variables using indicators chosen on the basis of the distributional form. Categorical variables will be described in percentages. Hypotheses on PaO2 / FiO2 performance will be verified through the T test for paired data if the distributional form allows it or alternatively the Wilcoxon test will be used. In this case we will proceed with a recalculation of the power study.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • ASST Monza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen or CPAP support.

Description

Inclusion Criteria:

  • Age> = 18 years old or <= 75 years old
  • Diagnosis of COVID related pneumonia requiring oxygen or CPAP support

Exclusion Criteria:

  • pregnant patients
  • patients with impaired consciousness and / or uncooperative
  • patients with NYHA class> II
  • patients with high proBNP
  • patients with COPD
  • contraindications evidenced by the physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
covid-19 pneumonia related patients
This study will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP.
Procedure: Prone position
The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index; the PP also prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).
Other Names:
  • PP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients in whom the prone position caused an increase in oxygenation
Time Frame: Until patient discharge from the hospital (approximately 1 month after enrollment)
Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.
Until patient discharge from the hospital (approximately 1 month after enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of prone position
Time Frame: Until patient discharge from the hospital (approximately 1 month after enrollment)
Measure the feasibility of the prone position in terms of patient comfort and health resources in a context of a national health emergency.
Until patient discharge from the hospital (approximately 1 month after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

  • Principal Investigator: Giuseppe Foti, Prof., ASST Monza-University Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2020

Primary Completion (ACTUAL)

April 9, 2020

Study Completion (ACTUAL)

May 9, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (ACTUAL)

April 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRON-COVID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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