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Clinical Trials/NCT04385823
NCT04385823
Completed
N/A

Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study

Hôpital Louis Mourier1 site in 1 country62 target enrollmentMarch 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Syndrome, Acute, Severe
Sponsor
Hôpital Louis Mourier
Enrollment
62
Locations
1
Primary Endpoint
Changes in ROX index
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

Detailed Description

Nasal High Flow oxygen therapy (NHF) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (AHRF). For various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), NHF seems to have been seldomly used during the current Covid-19 epidemic in France. However, the World Health Organization, and other scientific societies list NHF among the possible options for ventilatory support. One of the risks however, identified with NHF is to delay an intubation that would have become necessary. This delay seems to be associated with a poorer prognosis for patients. The respiratory-oxygenation index (termed ROX index) (defined as the ratio of pulse oximetry (SpO2) over inspired fraction in oxygen (FiO2) over respiratory rate (RR); SpO2/FiO2/RR) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on NHF for AHRF. In investigators'ICU, NHF is used in patients admitted for AHRFrelated to Covid-19 and the ROX index is measured and monitoring in investigators' patients. Investigators' initial experience - consistent with feedback from other ICUs - suggests that the respiratory rate of patients with Covid-19-related AHRF is sometimes lower than would be expected given the depth of the hypoxemia. In this case, the ROX index thresholds previously identified for predicting the success or failure of NHF could be different in the case of Covid-19-associated AHRF. The purpose of this work is to describe the use of NHF in Covid-19 patients with AHRF and the evolution of the ROX score over time in patients initially treated with NHF.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
May 4, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital Louis Mourier
Responsible Party
Principal Investigator
Principal Investigator

Prof Jean-Damien RICARD

Head Medico-surgical ICU

Hôpital Louis Mourier

Eligibility Criteria

Inclusion Criteria

  • Covid-19 pneumonia
  • acute hypoxemic respiratory failure
  • need for nasal high flow therapy as first line therapy
  • admission to intensive care

Exclusion Criteria

  • intubation prior to NHF therapy

Outcomes

Primary Outcomes

Changes in ROX index

Time Frame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

values of ROX index during ICU stay

Secondary Outcomes

  • NHF failure(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • NHF flow(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • NHF inspired fraction in oxygen(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • oxygenation(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • respiratory status(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • prediction of intubation(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • prediction of NHF success(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)

Study Sites (1)

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