Acute Lung InjuryPhase 2/3FLORALINCT01320384
Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)
A Phase 2/3 study testing O2 conventional, O2-HFN : high flow nasal oxygen therapy and O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation in people with Acute Lung Injury and Acute Respiratory Failure, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation : 1. conventional oxygen therapy (O2 conventional) 2. high flow nasal oxygen therapy (O2-HFN) 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Failure
- What is being tested?
- O2 conventional, O2-HFN : high flow nasal oxygen therapy and O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jul 2013
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypoxemic and no hypercapnic acute respiratory failure :
- severe dyspnea at rest with a respiratory rate >25 breaths/min
- PaO2/FiO2 <300
- PaCO2 <45 mmHg,
Who cannot join
- age <18 years
- NPPV contraindications
- past history of respiratory chronic disease (COPD, cystic fibrosis…)
- cardiac pulmonary edema
- Pre-defined intubation
- other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
- profound aplasia (white cells count <1000/mm 3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :
- conventional oxygen therapy (O2 conventional)
- high flow nasal oxygen therapy (O2-HFN)
- association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).
- Conditions
- Acute Lung Injury, Acute Respiratory Failure
- Being tested
- O2 conventional, O2-HFN : high flow nasal oxygen therapy, O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
- Keywords
- ALI
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2 conventionalOther
standard low flow therapy
O2-HFN : high flow nasal oxygen therapyDevice
The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilationDevice
The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
| Study group | Role | What they receive |
|---|---|---|
| O2 conventional : standard low flow therapy | Active comparator | in order to obtain a SpO2>92% Receives: Other: O2 conventional |
| O2-HNF : high flow nasal oxygen therapy | Experimental | set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%. Receives: Device: O2-HFN : high flow nasal oxygen therapy |
| O2-HFN/NPPV | Experimental | cycling of NIV and O2-HDN Receives: Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Measured: at day 28
Secondary outcomes (2)
mechanical ventilation-free to day 28
Measured: 28 days
ICU morbidity
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320384
- Sponsor's protocol ID
- FLORALI
- Acronym
- FLORALI
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2010
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Demoule A, Baptiste A, Thille AW, Similowski T, Ragot S, Prat G, Mercat A, Girault C, Carteaux G, Boulain T, Perbet S, Decavele M, Belin L, Frat JP; from the REVA Network (Research Network in Mechanical Ventilation). Dyspnea is severe and associated with a higher intubation rate in de novo acute hypoxemic respiratory failure. Crit Care. 2024 May 23;28(1):174. doi: 10.1186/s13054-024-04903-5.
PubMed 38783367Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
- ClinicalTrials.gov ID
- NCT01320384
- Acronym / sponsor ID
- FLORALI / FLORALI
- Conditions
- Acute Lung Injury, Acute Respiratory Failure
- Keywords
- ALI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Mar 2011 (estimated)
- 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, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :
- conventional oxygen therapy (O2 conventional)
- high flow nasal oxygen therapy (O2-HFN)
- association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| O2 conventional : standard low flow therapy | Active comparator | Other: O2 conventionalin order to obtain a SpO2>92% |
| O2-HNF : high flow nasal oxygen therapy | Experimental | Device: O2-HFN : high flow nasal oxygen therapyset between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%. |
| O2-HFN/NPPV | Experimental | Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilationcycling of NIV and O2-HDN |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypoxemic and no hypercapnic acute respiratory failure :
- severe dyspnea at rest with a respiratory rate >25 breaths/min
- PaO2/FiO2 <300
- PaCO2 <45 mmHg,
Key exclusion criteria (7 listed)
- age <18 years
- NPPV contraindications
- past history of respiratory chronic disease (COPD, cystic fibrosis…)
- cardiac pulmonary edema
- Pre-defined intubation
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 |
|---|---|---|
| O2 conventionalstandard low flow therapy | Other | O2 conventional : standard low flow therapy |
| O2-HFN : high flow nasal oxygen therapyThe patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%. | Device | O2-HNF : high flow nasal oxygen therapy |
| O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilationThe patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2. | Device | O2-HFN/NPPV |
Primary outcome
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Time frame: at day 28
2 secondary outcomes
mechanical ventilation-free to day 28
Time frame: 28 days
ICU morbidity
Time frame: at day 28
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 11 Oct 2016.
- Derived from this study: PubMed 38783367Demoule A, Baptiste A, Thille AW, Similowski T, Ragot S, Prat G, Mercat A, Girault C, Carteaux G, Boulain T, Perbet S, Decavele M, Belin L, Frat JP; from the REVA Network (Research Network in Mechanical Ventilation). Dyspnea is severe and associated with a higher intubation rate in de novo acute hypoxemic respiratory failure. Crit Care. 2024 May 23;28(1):174. doi: 10.1186/s13054-024-04903-5.
- Derived from this study: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing O2 conventional, O2-HFN : high flow nasal oxygen therapy and O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation in people with Acute Lung Injury and Acute Respiratory Failure, run by Poitiers University Hospital at 1 site 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 4 inclusion and 7 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (time frame: at day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320384, which also lists 2 linked publications.
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 11 Oct 2016.