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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03447457

Enrollment

102

Registered

2018-02-27

Start date

2015-12-01

Completion date

2017-05-30

Last updated

2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Brief summary

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.

Detailed description

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%.

Interventions

DEVICEHigh-flow oxygen

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%

DEVICEStandard oxygen

nasal cannula, face mask or non-rebreathing reservoir mask

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

FLORAL-ER is a before/after study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame	Description
complete regression of respiratory failure	one hour after initiation of oxygen strategies	respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026