Official Title
Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards
Brief Summary

Prospective, observational, multicenter study aiming to evaluate the number of COVID-19 pneumonia related patients treated with non-invasive ventilatory support outside the intensive care unit. In addition, the study aims to obtain information related to the clinical characteristics and hospital results of these patients.

Detailed Description

In February 2020, the first case of transmission of the syndrome, indicated as COVID-19, was
reported in Italy. Unfortunately, during March 2020, the syndrome spread rapidly throughout
the country, affecting tens of thousands of patients, including several thousands have
requested hospitalization and some hospitalization in intensive care, putting a strain on the
entire regional health system.

Patients that present intermediate severity of the infection are often treated with
non-invasive ventilatory support which includes high-flow nasal cannulas (HFNC), non-invasive
ventilation (NIV), continuous positive airway pressure (CPAP) through face mask or helmet
(helmet).

The exponential growth in the number of patients has made the massive use of these devices
necessary even outside the intensive or semi-intensive wards where they are traditionally
used.

Epidemiological knowledge regarding the type of patients treated with this strategy and the
outcome of these patients are limited, but very important in a context of emergency.

Thus, the objective of this prospective multicenter study is to evaluate the number of
patients with COVID-19 related pneumonia, treated with non-invasive ventilatory support
outside the intensive care unit and to evaluate the clinical characteristics and hospital
outcomes of these patients.

SAMPLE SIZE (n. Patients):

The study will collect all patients with the inclusion criteria, so the study size being by
definition equal to the maximum size.

STUDY DESIGN:

Patients will be enrolled on a single day (March 26, 2020 or March 31, 2020 chosen by the
participating centres).

Total duration of the Study: 5 months (enrollment, collection and analysis of data).

Enrollment Start: March 26, 2020. Enrollment Closure: March 31, 2020. End of the Study
(indicative date, last visit, last patient): May 2020.

The patient will be enrolled in the study when informed consent is obtained.

In this phase, the following data are collected:

- Patient registration;

- Demographic and anthropometric data;

- Comorbidity

- Hospitalization data;

- Ventilation / Hemodynamics data;

- Blood chemistry tests.

Upon discharge other data will be collected such as the necessary intubation or intubation
date.

STATISTICAL ANALYSIS:

The enrolled cases will be counted and the percentages of the three types of non-invasive
ventilatory supports will be specifically described by centre. The heterogeneity of these
percentages will be assessed through a model with mixed effects.

The anamnestic and clinical data of the enrolled patients will be analysed through
descriptive statistics on continuous quantitative variables.

The impact of the type of ventilation and of the blood chemistry parameters and aspects of
comorbidity will be assessed with reference to the probability of developing a transition to
the death and to hospitalization in intensive care through a multinomial model.

These factors will also be included in a logistic model with outcome defined by patient
survival.

Completed
COVID-19

Device: Non-invasive ventilatory support

All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests.
Other Name: Array

Eligibility Criteria

Inclusion Criteria:

- Age> = 18 years

- Diagnosis of COVID-related pneumonia requiring non-invasive ventilatory support
(high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

Exclusion Criteria:

- Explicit refusal to participate in the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

Policlinico San Marco - Ospedale Zingonia
Bergamo, BG, Italy

ASST Papa Giovanni XXIII - Bergamo
Bergamo, Italy

Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi
Bologna, Italy

ASST Spedali Civili - Brescia
Brescia, Italy

ASST Valle Olona - Ospedale di Busto Arsizio
Busto Arsizio, Italy

ASST Lariana - Ospedale Sant'Anna
Como, Italy

ASST Crema - Ospedale Maggiore di Crema
Crema, Italy

ASST Cremona - Ospedale di Cremona
Cremona, Italy

Istituto Clinico Humanitas Gavazzeni
Cremona, Italy

ASST Garda - Presidio di Desenzano del Garda
Desenzano Del Garda, Italy

ASST Monza - Desio
Desio, Italy

ASST Spedali Civili -Ospedale di Gardone Val Trompia
Gardone Val Trompia, Italy

ASST Lecco - Ospedale "A. Manzoni"
Lecco, Italy

ASST Ovest milanese - Ospedale di Legnano
Legnano, Italy

ASST Lodi - Ospedale Maggiore di Lodi
Lodi, Italy

ASST OVEST Milanese - Ospedale di Magenta
Magenta, Italy

ASST Garda - Ospedale di Manerbio
Manerbio, Italy

ASST Mantova - Ospedale Carlo Poma
Mantova, Italy

ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola
Melzo, Italy

ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni
Milano, Italy

ASST Fatebenefratelli - Sacco
Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Italy

Ospedale San Giuseppe
Milano, Italy

ASST Spedali Civili -Presidio Ospedaliero di Montichiari
Montichiari, Italy

ASST Monza - Ospedale San Gerardo
Monza, Italy

Fondazione IRCCS Policlinico San Matteo - Pavia
Pavia, Italy

Policlinico San Pietro
Ponte San Pietro, Italy

Istituto Clinico Humanitas Rozzano
Rozzano, Italy

ASST Valle Olona - Ospedale di Saronno
Saronno, Italy

ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio
Treviglio, Italy

Ospedale di Circolo e Fondazione Macchi - Varese
Varese, Italy

ASST Vimercate - Ospedale di Vimercate
Vimercate, Italy

ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
Vizzolo Predabissi, Italy

University of Milano Bicocca
NCT Number
Keywords
Coronavirus
sars-covid-2
Coronavirus infection
MeSH Terms
COVID-19