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 (NORMO2)

September 4, 2023 updated by: Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

80 hospital sites across the United States

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full analysis
All eligible patients.
Device: High flow nasal oxygen (HFNO, more than 15 L/min)
Non-invasive respiratory support strategy
Other Names:
  • Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  • Conventional oxygen (COT, between 10 - 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)
Non-invasive respiratory support strategy
Other Names:
  • Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  • Conventional oxygen (COT, between 10 - 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)
Non-invasive respiratory support strategy
Other Names:
  • 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
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)
Non-invasive respiratory support strategy
Other Names:
  • Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  • Conventional oxygen (COT, between 10 - 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)
Non-invasive respiratory support strategy
Other Names:
  • Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  • Conventional oxygen (COT, between 10 - 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)
Non-invasive respiratory support strategy
Other Names:
  • Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)
  • Conventional oxygen (COT, between 10 - 15 L/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients requiring invasive mechanical ventilation
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality at day 30
Time Frame: 30 days
30 days
ICU-free days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-D0C3E4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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