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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, France, 92700

Sponsors and Collaborators

Hôpital Louis Mourier

Investigators

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

More Information

Publications:

Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-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.

Roca O, Messika J, Caralt B, García-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.

• 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
• 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

Additional relevant MeSH terms:

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