- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447457
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
February 26, 2018 updated by: Poitiers University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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%.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Niort, France, 79000
- CHG de Niort
-
Poitiers, France, 86000
- CHU Poitiers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: standard oxygen group
Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir
|
nasal cannula, face mask or non-rebreathing reservoir mask
|
Other: 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
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one hour after initiation of oxygen strategies
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jean MACE, MD, Centre Hospitalier de Niort
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
May 30, 2017
Study Completion (Actual)
May 30, 2017
Study Registration Dates
First Submitted
February 19, 2018
First Submitted That Met QC Criteria
February 26, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
February 27, 2018
Last Update Submitted That Met QC Criteria
February 26, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLORAL-ER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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