Non-invasive Ventilatory Support of Patients Affected by COVID-19

NCT ID: NCT04382235

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 909 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-05-31

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.

Conditions

Covid-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Covid-19 related Pneumonia patients

The cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support.

Non-invasive ventilatory support

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

High-flow nasal cannulas (HFNC); Non-invasive ventilation (NIV); Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

Milan, , Italy

ASST Fatebenefratelli - Sacco

Milan, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Ospedale San Giuseppe

Milan, , 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

Countries

Italy

References

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

Reference Type: BACKGROUND

PMID: 31978945 (View on PubMed)

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

Reference Type: BACKGROUND

PMID: 31986264 (View on PubMed)

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

Reference Type: BACKGROUND

PMID: 32091533 (View on PubMed)

Bellani G, Grasselli G, Cecconi M, Antolini L, Borelli M, De Giacomi F, Bosio G, Latronico N, Filippini M, Gemma M, Giannotti C, Antonini B, Petrucci N, Zerbi SM, Maniglia P, Castelli GP, Marino G, Subert M, Citerio G, Radrizzani D, Mediani TS, Lorini FL, Russo FM, Faletti A, Beindorf A, Covello RD, Greco S, Bizzarri MM, Ristagno G, Mojoli F, Pradella A, Severgnini P, Da Macalle M, Albertin A, Ranieri VM, Rezoagli E, Vitale G, Magliocca A, Cappelleri G, Docci M, Aliberti S, Serra F, Rossi E, Valsecchi MG, Pesenti A, Foti G. Noninvasive Ventilatory Support of Patients with COVID-19 outside the Intensive Care Units (WARd-COVID). Ann Am Thorac Soc. 2021 Jun;18(6):1020-1026. doi: 10.1513/AnnalsATS.202008-1080OC.

Reference Type: DERIVED

PMID: 33395553 (View on PubMed)

Other Identifiers

WARd-COVID

Identifier Type: -

Identifier Source: org_study_id