Back to resultsEarly Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Primary Purpose
Acute Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-flow oxygen
Standard oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Failure
Eligibility Criteria
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,
Sites / Locations
- CHG de Niort
- CHU Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
standard oxygen group
High-flow oxygen group
Arm Description
Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir
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
Outcomes
Primary Outcome Measures
complete regression of respiratory failure
respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing
Secondary Outcome Measures
Full Information
NCT ID
NCT03447457
First Posted
February 19, 2018
Last Updated
February 26, 2018
Sponsor
Poitiers University Hospital
Collaborators
Centre Hospitalier de Niort
1. Study Identification
Unique Protocol Identification Number
NCT03447457
Brief Title
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Official Title
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
Centre Hospitalier de Niort
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
FLORAL-ER is a before/after study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard oxygen group
Arm Type
Other
Arm Description
Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir
Arm Title
High-flow oxygen group
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
High-flow oxygen
Other Intervention Name(s)
High-flow nasal cannula oxygen therapy
Intervention Description
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
Intervention Name(s)
Standard oxygen
Intervention Description
nasal cannula, face mask or non-rebreathing reservoir mask
Primary Outcome Measure Information:
Title
complete regression of respiratory failure
Description
respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing
Time Frame
one hour after initiation of oxygen strategies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean MACE, MD
Organizational Affiliation
Centre Hospitalier de Niort
Official's Role
Study Director
Facility Information:
Facility Name
CHG de Niort
City
Niort
ZIP/Postal Code
79000
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
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