COVID-19, Hypoxemic Respiratory Failure
Conditions
Brief summary
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.
Interventions
Non-invasive respiratory support strategy
Sponsors
Study design
Eligibility
Inclusion criteria
* Sars-Cov-2 infection * hospital admission (emergency department, inpatient or ICU) * hypoxemic respiratory failure, defined as P/F ratio below or including 200
Exclusion criteria
* hypercapnia (PCO2 \> 45 mmHG in combination with acidemia (pH \< 7.35)) * pregnancy * do not resuscitate order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients requiring invasive mechanical ventilation | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Mortality at day 30 | 30 days |
| ICU-free days | 30 days |
Countries
Netherlands