NORMO2: The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Full analysis All eligible patients. |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
| P/F ratio subgroups Patients with a P/F ratio split in groups of <=100; 100-150; 150-200 |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
| Respiratory rate subgroups Patients with a respiratory rate split in groups of <=25; >25 breaths/min |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
| Body mass index (BMI) subgroups Patients with BMI split in groups of <=25; 25-30; 30-35; >35 kg/m^2 |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
| Immunocompromised subgroups Immunocompromised patients due to medication or an underlined condition. |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
| Intensive care unit (ICU) subgroup Only patients eligible within 24 hours of ICU admission. |
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients requiring invasive mechanical ventilation [30 days]
Secondary Outcome Measures
- Mortality at day 30 [30 days]
- ICU-free days [30 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus MC | Rotterdam | Zuid-Holland | Netherlands | 3015GD |
Sponsors and Collaborators
- Amsterdam UMC, location VUmc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RP-D0C3E4