NCT06033560

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

The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	High flow nasal oxygen (HFNO, more than 15 L/min)	Non-invasive respiratory support strategy

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: Netherlands