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

Completed

• Conditions: Respiratory Syndrome, Acute, Severe; Hypoxic Respiratory Failure; Viral Pneumonia

• Registration Number: NCT04385823
• Lead Sponsor: Hôpital Louis Mourier

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.

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-05
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in ROX index	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

Name	Time	Method
NHF failure	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	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	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	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	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	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	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)

Trial Locations

Locations (1)

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Colombes, France