Use of High Flow Nasal Cannula Oxygen and Covid-19 Acute Hypoxemic Respiratory Failure

May 12, 2020 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

62

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

  • France
      • Colombes, France, 92700
        • Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all adult patients admitted to the ICU with proven Covid-19 pneumonia and acute hypoxemic respiratory failure requiring supplemental oxygen administered via NHF

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NHF failure
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
percentage of patients requiring intubation
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
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
level of flow used with NHF
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
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
level of inspired fraction in oxygen used with NHF
from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
oxygenation
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
level of pulse oxymetry during NHF therapy
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
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
respiratory rate during NHF therapy
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
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
defining the values of ROX index associated with 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
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
defining the values of ROX index associated with NHF success (no intubation required)
from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Collaborators and Investigators

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

Sponsor

Hôpital Louis Mourier

Investigators

  • Principal Investigator: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2020

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLM_JDR9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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