Clinical trial NCT04385823: Use of High Flow Nasal Cannula Oxygen and Covid-19 Acute Hypoxemic Respiratory Failure
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syndrome, Acute, Severe
Hypoxic Respiratory Failure
Viral Pneumonia
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Changes in ROX index
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary outcomes:
measure: NHF failure
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: NHF flow
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: NHF inspired fraction in oxygen
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: oxygenation
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: respiratory status
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: prediction of intubation
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
measure: prediction of NHF success
timeFrame: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Damien Ricard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
citation: Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.