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

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ClinicalTrials.gov Identifier: NCT04385823
Recruitment Status : Completed
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

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.

Condition or disease Intervention/treatment
Respiratory Syndrome, Acute, Severe Hypoxic Respiratory Failure Viral Pneumonia Device: patients receiving nasal high flow

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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 4, 2020



Intervention Details:
  • Device: patients receiving nasal high flow
    patients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385823


Locations
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France
Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
Colombes, France, 92700
Sponsors and Collaborators
Hôpital Louis Mourier
Investigators
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Principal Investigator: Jean-Damien Ricard, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Prof Jean-Damien RICARD, Head Medico-surgical ICU, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT04385823    
Other Study ID Numbers: HLM_JDR9
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Severe Acute Respiratory Syndrome
Coronavirus Infections
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections