Acute Respiratory FailureNCT03447457
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
A study testing High-flow oxygen and Standard oxygen in people with Acute Respiratory Failure, run by Poitiers University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High-flow oxygen and Standard oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2015to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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%.
- Conditions
- Acute Respiratory Failure
- Being tested
- High-flow oxygen, Standard oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow oxygenDevice
Also called High-flow nasal cannula oxygen therapy
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%
Standard oxygenDevice
nasal cannula, face mask or non-rebreathing reservoir mask
| Study group | Role | What they receive |
|---|---|---|
| standard oxygen group | Other | Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir Receives: 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 Receives: Device: High-flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete regression of respiratory failure
respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing
Measured: one hour after initiation of oxygen strategies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Dec 2015
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- FLORAL-ER is a before/after study
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Niort
- Responsible party
- Sponsor
- Investigators
- Jean MACE, MD, Study director, Centre Hospitalier de Niort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447457
- Sponsor's protocol ID
- FLORAL-ER
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03447457
- Acronym / sponsor ID
- FLORAL-ER
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Niort
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- FLORAL-ER is a before/after study
| Arm | Type | Receives |
|---|---|---|
| standard oxygen group | Other | Device: Standard oxygenPatients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir |
| High-flow oxygen group | Other | Device: High-flow oxygenPatients are treated with high-flow nasal cannula oxygen continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- de novo acute respiratory failure cowith the following criteria: a respiratory rate > 25 b/min, or signs of increased work of breathing.
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow oxygenAlso: High-flow nasal cannula oxygen therapyHFNC 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% | Device | High-flow oxygen group |
| Standard oxygennasal cannula, face mask or non-rebreathing reservoir mask | Device | standard oxygen group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: No
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Influence of Patient Positioning During Nasal Lavage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean MACE, MD study director
Centre Hospitalier de Niort
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow oxygen and Standard oxygen in people with Acute Respiratory Failure, run by Poitiers University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete regression of respiratory failure (time frame: one hour after initiation of oxygen strategies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.