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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04385823
Enrollment
62
Registered
2020-05-13
Start date
2020-03-01
Completion date
2020-05-04
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Respiratory Failure, Respiratory Syndrome, Acute, Severe, Viral Pneumonia

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.

Interventions

DEVICEpatients receiving nasal high flow

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

Sponsors

Hôpital Louis Mourier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in ROX indexfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsvalues of ROX index during ICU stay

Secondary

MeasureTime frameDescription
NHF flowfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthslevel of flow used with NHF
NHF inspired fraction in oxygenfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthslevel of inspired fraction in oxygen used with NHF
oxygenationfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthslevel of pulse oxymetry during NHF therapy
NHF failurefrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthspercentage of patients requiring intubation
prediction of intubationfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsdefining the values of ROX index associated with intubation
prediction of NHF successfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsdefining the values of ROX index associated with NHF success (no intubation required)
respiratory statusfrom date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsrespiratory rate during NHF therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026