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Clinical Trials/NCT06033560
NCT06033560Active, not recruitingNot Applicable

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

Amsterdam UMC, location VUmc1 site in 1 country6,000 target enrollmentStarted: September 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
6,000
Locations
1
Primary Endpoint
Proportion of patients requiring invasive mechanical ventilation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Proportion of patients requiring invasive mechanical ventilation

Time Frame: 30 days

Secondary Outcomes

  • ICU-free days(30 days)
  • Mortality at day 30(30 days)

Investigators

Sponsor
Amsterdam UMC, location VUmc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof.dr. L.M.A. Heunks

Professor

Erasmus Medical Center

Study Sites (1)

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