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

NCT06033560 | Unknown

• 1 other identifier: RP-D0C3E4
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients requiring invasive mechanical ventilation

  30 days

Secondary Outcomes (2)

• Mortality at day 30

  30 days

• ICU-free days

  30 days

Study Arms (6)

Full analysis

All eligible patients.

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

P/F ratio subgroups

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

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

Respiratory rate subgroups

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

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

Body mass index (BMI) subgroups

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

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

Immunocompromised subgroups

Immunocompromised patients due to medication or an underlined condition.

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

Intensive care unit (ICU) subgroup

Only patients eligible within 24 hours of ICU admission.

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

Interventions

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

Non-invasive respiratory support strategy

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

Body mass index (BMI) subgroups; Full analysis; Immunocompromised subgroups; Intensive care unit (ICU) subgroup; P/F ratio subgroups; Respiratory rate subgroups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 hospital sites across the United States

You may qualify if:

• Sars-Cov-2 infection
• hospital admission (emergency department, inpatient or ICU)
• hypoxemic respiratory failure, defined as P/F ratio below or including 200

You may not qualify if:

• hypercapnia (PCO2 \> 45 mmHG in combination with acidemia (pH \< 7.35))
• pregnancy
• do not resuscitate order

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Noninvasive Ventilation; Continuous Positive Airway Pressure; Stretchers

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Positive-Pressure Respiration; Beds; Equipment and Supplies, Hospital; Equipment and Supplies; Transportation of Patients; Emergency Medical Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 6, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)