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

Viral Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385823
• Other study ID #: HLM_JDR9
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2020
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Hypoxic Respiratory Failure
• Pneumonia
• Pneumonia, Viral
• Respiratory Insufficiency
• Respiratory Syndrome, Acute, Severe
• Severe Acute Respiratory Syndrome
• Viral Pneumonia

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ROX index	values of ROX index during ICU stay	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	NHF failure	percentage of patients requiring intubation	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	NHF flow	level of flow used with NHF	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	NHF inspired fraction in oxygen	level of inspired fraction in oxygen used with NHF	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	oxygenation	level of pulse oxymetry during NHF therapy	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	respiratory status	respiratory rate during NHF therapy	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	prediction of intubation	defining the values of ROX index associated with intubation	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
Secondary	prediction of NHF success	defining the values of ROX index associated with NHF success (no intubation required)	from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months