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 (NORMO2)

Amsterdam UMC, location VUmc

Status: Active, not recruiting

Conditions: COVID-19; Hypoxemic Respiratory Failure

Treatments: Device: High flow nasal oxygen (HFNO, more than 15 L/min)

Study type: Observational

Funder types: Other

Identifiers

NCT06033560

RP-D0C3E4

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6,000 participants in 6 patient groups

Full analysis

Description:

All eligible patients.

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)

P/F ratio subgroups

Description:

Patients with a P/F ratio split in groups of \<=100; 100-150; 150-200

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)

Respiratory rate subgroups

Description:

Patients with a respiratory rate split in groups of \<=25; \>25 breaths/min

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)

Body mass index (BMI) subgroups

Description:

Patients with BMI split in groups of \<=25; 25-30; 30-35; \>35 kg/m\^2

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)

Immunocompromised subgroups

Description:

Immunocompromised patients due to medication or an underlined condition.

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)

Intensive care unit (ICU) subgroup

Description:

Only patients eligible within 24 hours of ICU admission.

Treatment:

Device: High flow nasal oxygen (HFNO, more than 15 L/min)