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Completed

NCT Number: NCT03447457

Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHG de Niort, Niort, France

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About this study

Prospective observational before-after study at the ED in two French centers.

Selection of patients with acute hypoxemic respiratory failure at the ED.

Application of oxygen strategy according to the period:

  • before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%.
  • after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • de novo acute respiratory failure cowith the following criteria: a respiratory rate > 25 b/min, or signs of increased work of breathing.

Main exclusion Criteria:

  • cardiogenic pulmonary edema,
  • acute exacerbation of chronic lung disease, respiratory acidosis (pH < 7.35 and PaCO2 > 50 mm Hg),
  • hemodynamic instability
  • Glasgow Coma Scale score of 12 points or less,
  • an urgent need for endotracheal intubation,

Treatment and study plan

High-flow oxygen

Device

HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%

Other names: High-flow nasal cannula oxygen therapy

Standard oxygen

Device

nasal cannula, face mask or non-rebreathing reservoir mask

Primary outcomes

  1. complete regression of respiratory failure

    Time frame: one hour after initiation of oxygen strategies

    respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Centre Hospitalier de Niort

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2018
Registry last updated
Feb 27, 2018

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

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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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