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Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.
Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.
The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full analysis | All eligible patients. |
| |
| P/F ratio subgroups | Patients with a P/F ratio split in groups of <=100; 100-150; 150-200 |
| |
| Respiratory rate subgroups | Patients with a respiratory rate split in groups of <=25; >25 breaths/min |
| |
| Body mass index (BMI) subgroups | Patients with BMI split in groups of <=25; 25-30; 30-35; >35 kg/m^2 |
| |
| Immunocompromised subgroups | Immunocompromised patients due to medication or an underlined condition. |
| |
| Intensive care unit (ICU) subgroup | Only patients eligible within 24 hours of ICU admission. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal oxygen (HFNO, more than 15 L/min) | Device | Non-invasive respiratory support strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring invasive mechanical ventilation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at day 30 | 30 days | |
| ICU-free days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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80 hospital sites across the United States
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3015GD | Netherlands |
Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.
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|
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| D045422 | Continuous Positive Airway Pressure |
| D058254 | Stretchers |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D011175 | Positive-Pressure Respiration |
| D001513 | Beds |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D014187 | Transportation of Patients |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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