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

COVID-19 Clinical Trial

— NORMO2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06033560
• Other study ID #: RP-D0C3E4
• Status: Active, not recruiting
• Start date: September 6, 2022
• Est. completion date: November 2023

Study information

• Verified date: September 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• COVID-19
• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients requiring invasive mechanical ventilation		30 days
Secondary	Mortality at day 30		30 days
Secondary	ICU-free days		30 days