Clinical trial NCT04365959: The Prone Position in Covid-19 Affected Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Keywords: COVID-19
sars-covid-2
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients in whom the prone position caused an increase in oxygenation
timeFrame: Until patient discharge from the hospital (approximately 1 month after enrollment)
Secondary outcomes:
measure: The feasibility of prone position
timeFrame: Until patient discharge from the hospital (approximately 1 month after enrollment)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST Monza
state: MB
Study officials:
affiliation: ASST Monza-University Milano Bicocca
name: Giuseppe Foti, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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