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

NCT ID: NCT03447457

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-05-30

Brief Summary

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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

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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%.

Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

FLORAL-ER is a before/after study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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standard oxygen group

Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir

Group Type OTHER

Standard oxygen

Intervention Type DEVICE

nasal cannula, face mask or non-rebreathing reservoir mask

High-flow oxygen group

Patients are treated with high-flow nasal cannula oxygen continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min

Group Type OTHER

High-flow oxygen

Intervention Type 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%

Interventions

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High-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%

Intervention Type DEVICE

Standard oxygen

nasal cannula, face mask or non-rebreathing reservoir mask

Intervention Type DEVICE

Other Intervention Names

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High-flow nasal cannula oxygen therapy

Eligibility Criteria

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Inclusion Criteria

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

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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Niort

OTHER

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean MACE, MD

Role: STUDY_DIRECTOR

Centre Hospitalier de Niort

Locations

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CHG de Niort

Niort, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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FLORAL-ER

Identifier Type: -

Identifier Source: org_study_id

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