Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
Study NCT ID:
NCT04382235
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2020-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Ventilatory Support of Patients Affected by COVID-19
Sponsor:
University of Milano Bicocca
Organization:
Study Overview
Official Title:
Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WARd-COVID
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: