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

NCT ID: NCT06033560

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-11-30

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.

Conditions

COVID-19; Hypoxemic Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Full analysis

All eligible patients.

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

P/F ratio subgroups

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

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

Respiratory rate subgroups

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

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

Body mass index (BMI) subgroups

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

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

Immunocompromised subgroups

Immunocompromised patients due to medication or an underlined condition.

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

Intensive care unit (ICU) subgroup

Only patients eligible within 24 hours of ICU admission.

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

Intervention Type: DEVICE

Non-invasive respiratory support strategy

Interventions

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

Non-invasive respiratory support strategy

Intervention Type: DEVICE

Other Intervention Names

Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure); Conventional oxygen (COT, between 10 - 15 L/min)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Prof.dr. L.M.A. Heunks

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

RP-D0C3E4

Identifier Type: -

Identifier Source: org_study_id