Acute Respiratory FailureFLORALI2NCT02668458
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
A study testing High Flow nasal canula oxygen therapy and Noninvasive ventilation in people with Acute Respiratory Failure and Intratracheal Intubation, run by Poitiers University Hospital at 27 sites in France.
Trial summary
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation: 1. NIV (Non Invasive Ventilation) 2. HFNC (High-flow nasal canula oxygen therapy) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Intratracheal Intubation
- What is being tested?
- High Flow nasal canula oxygen therapy and Noninvasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 27 sitesFrance
- Study dates
- Apr 2016to Jan 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
Main inclusion Criteria:
- acute hypoxemic respiratory failure requiring endotracheal intubation
Main exclusion Criteria:
- coma
- NIV contraindication
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
CHU Angers
Angers
CHU La cavale Blanche
Brest
CHU louis MOURIER
Colombes
Chu Mondor
Créteil
CHU Dijon
Dijon
CH Vendée
La Roche/Yon
CH La Rochelle
La Rochelle
CHU Lille
Lille
Limoges University Hospital
Limoges, 87042
CH St Joseph St Luc
Lyon
Chu E. Herriot
Lyon
LYON Sud
Lyon
CHU marseille
Marseille
CH
Montauban
CHU Lapeyronie
Montpellier
Hopital de l'Archet
Nice
CHU La Source
Orléans
Chu Cochin
Paris
CHU La Pitié Salpétrière
Paris
Chu Tenon
Paris
CHU Guadeloupe
Pointe à Pitre
CHU Poitiers
Poitiers, 86000
University Hospital of Poitiers
Poitiers, 86021
Hôpital C. NICOLLE
Rouen
CHU Strasbourg
Strasbourg
Hôpital FOCH
Suresnes
Chu Tours
Tours
About this study
Official title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
- NIV (Non Invasive Ventilation)
- HFNC (High-flow nasal canula oxygen therapy)
Read the detailed description
Design:
Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.
Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.
Randomized study, inclusion in two groups: NIV or HFNC.
Experimental group:
NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.
Control group:
NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
Duration of participation of each patient: 28 days
- Being tested
- High Flow nasal canula oxygen therapy, Noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal canula oxygen therapyProcedure or surgery
Pre-oxygenation with high-flow nasal canula oxygen therapy
Noninvasive ventilationProcedure or surgery
Pre-oxygenation with non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| NIV | Experimental | NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. Receives: Procedure: Noninvasive ventilation |
| HFNC | Active comparator | High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2 Receives: Procedure: High Flow nasal canula oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe desaturation as defined by a pulse oxymetry below 80%
drop below 80% of pulse oxymetry measurement
Measured: through five minutes after preoxygenation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668458
- Sponsor's protocol ID
- FLORALI 2
- Acronym
- FLORALI2
- Status last verified
- Oct 2017
- First submitted
- 19 Jan 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.
PubMed 34292408Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.
PubMed 30898520Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.
PubMed 29275345
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
- ClinicalTrials.gov ID
- NCT02668458
- Acronym / sponsor ID
- FLORALI2 / FLORALI 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Jan 2016 (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 evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
- NIV (Non Invasive Ventilation)
- HFNC (High-flow nasal canula oxygen therapy)
Detailed description
Design:
Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.
Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.
Randomized study, inclusion in two groups: NIV or HFNC.
Experimental group:
NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.
Control group:
NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
Duration of participation of each patient: 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | Experimental | Procedure: Noninvasive ventilationNIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. |
| HFNC | Active comparator | Procedure: High Flow nasal canula oxygen therapyHigh-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 nasal canula oxygen therapyPre-oxygenation with high-flow nasal canula oxygen therapy | Procedure or surgery | HFNC |
| Noninvasive ventilationPre-oxygenation with non-invasive ventilation | Procedure or surgery | NIV |
Primary outcome
Severe desaturation as defined by a pulse oxymetry below 80%
Time frame: through five minutes after preoxygenation period
drop below 80% of pulse oxymetry measurement
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 2017.
- Derived from this study: PubMed 34292408Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.
- Derived from this study: PubMed 30898520Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.
- Derived from this study: PubMed 29275345Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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.
27 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 nasal canula oxygen therapy and Noninvasive ventilation in people with Acute Respiratory Failure and Intratracheal Intubation, run by Poitiers University Hospital at 27 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?
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 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Severe desaturation as defined by a pulse oxymetry below 80% (time frame: through five minutes after preoxygenation period). 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 NCT02668458, which also lists 3 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 2017.