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Clinical Trials/NCT06033560
NCT06033560
Active, not recruiting
Not 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 enrollmentSeptember 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Amsterdam UMC, location VUmc
Enrollment
6000
Locations
1
Primary Endpoint
Proportion of patients requiring invasive mechanical ventilation
Status
Active, not recruiting
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2022
End Date
November 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

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

Prof.dr. L.M.A. Heunks

Professor

Erasmus Medical Center

Eligibility Criteria

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)

Study Sites (1)

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