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

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

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
France | |
Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris | |
Colombes, France, 92700 |
Principal Investigator: | Jean-Damien Ricard, MD, PhD | Assistance Publique - Hôpitaux de Paris |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia, Viral Severe Acute Respiratory Syndrome Respiratory Insufficiency Pneumonia Respiratory Tract Infections Infections Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |