Non-invasive Ventilatory Support of Patients Affected by COVID-19
- Conditions
- Covid-19
- Interventions
- Device: Non-invasive ventilatory support
- Registration Number
- NCT04382235
- Lead Sponsor
- University of Milano Bicocca
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 909
- 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)
- Explicit refusal to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Covid-19 related Pneumonia patients Non-invasive ventilatory support The cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support.
- Primary Outcome Measures
Name Time Method The number of patients treated with non-invasive ventilation devices. Until patient discharge from the hospital (approximately 5 months) The first purpose of the study is to evaluate the number of COVID-19 related pneumonia patients treated with devices for non-invasive ventilation outside intensive care units.
- Secondary Outcome Measures
Name Time Method Incidence of organ failure Until patient discharge from the hospital (approximately 5 months) Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of organ failure.
Incidence of patients requiring mechanical ventilation Until patient discharge from the hospital (approximately 5 months) Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of patients requiring mechanical ventilation.
Duration of hospitalization Until patient discharge from the hospital (approximately 5 months) Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: duration of hospitalization.
Clinical outcome at hospital discharge Until patient discharge from the hospital (approximately 5 months) Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: clinical outcome at hospital discharge.
Trial Locations
- Locations (34)
ASST Lariana - Ospedale Sant'Anna
🇮🇹Como, Italy
ASST Lecco - Ospedale "A. Manzoni"
🇮🇹Lecco, 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 CÃ 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
ASST Valle Olona - Ospedale di Saronno
🇮🇹Saronno, Italy
Istituto Clinico Humanitas Rozzano
🇮🇹Rozzano, 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
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 Crema - Ospedale Maggiore di Crema
🇮🇹Crema, Italy
Istituto Clinico Humanitas Gavazzeni
🇮🇹Cremona, Italy
ASST Cremona - Ospedale di Cremona
🇮🇹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 Ovest milanese - Ospedale di Legnano
🇮🇹Legnano, Italy
Policlinico San Marco - Ospedale Zingonia
🇮🇹Bergamo, BG, Italy