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NCT Number: NCT04385823

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

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.

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Key information

Conditions

Respiratory Syndrome, Acute, Severe Coronaviridae Infections Coronavirus Infections Hypoxic Respiratory Failure Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Viral Pneumonia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patients receiving nasal high flow

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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