NCT03447457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

February 19, 2018

Last Update Submit

February 26, 2018

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • complete regression of respiratory failure

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

    one hour after initiation of oxygen strategies

Study Arms (2)

standard oxygen group

OTHER

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

Device: Standard oxygen

High-flow oxygen group

OTHER

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

Device: High-flow oxygen

Interventions

High-flow oxygenDEVICE

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%

Also known as: High-flow nasal cannula oxygen therapy
High-flow oxygen group
Standard oxygenDEVICE

nasal cannula, face mask or non-rebreathing reservoir mask

standard oxygen group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHG de Niort

Niort, 79000, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

Study Officials

  • Jean MACE, MD

    Centre Hospitalier de Niort

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: FLORAL-ER is a before/after study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 27, 2018

Study Start

December 1, 2015

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)