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

Active, not recruiting

• Conditions: COVID-19; Hypoxemic Respiratory Failure
• Interventions: Device: High flow nasal oxygen (HFNO, more than 15 L/min)

• Registration Number: NCT06033560
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-06
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full analysis	High flow nasal oxygen (HFNO, more than 15 L/min)	All eligible patients.
P/F ratio subgroups	High flow nasal oxygen (HFNO, more than 15 L/min)	Patients with a P/F ratio split in groups of \<=100; 100-150; 150-200
Body mass index (BMI) subgroups	High flow nasal oxygen (HFNO, more than 15 L/min)	Patients with BMI split in groups of \<=25; 25-30; 30-35; \>35 kg/m\^2
Intensive care unit (ICU) subgroup	High flow nasal oxygen (HFNO, more than 15 L/min)	Only patients eligible within 24 hours of ICU admission.
Respiratory rate subgroups	High flow nasal oxygen (HFNO, more than 15 L/min)	Patients with a respiratory rate split in groups of \<=25; \>25 breaths/min
Immunocompromised subgroups	High flow nasal oxygen (HFNO, more than 15 L/min)	Immunocompromised patients due to medication or an underlined condition.

Primary Outcome Measures

Name	Time	Method
Proportion of patients requiring invasive mechanical ventilation	30 days

Secondary Outcome Measures

Name	Time	Method
ICU-free days	30 days
Mortality at day 30	30 days

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands