Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study) (FLORALI)

Tracking Information
First Submitted Date ICMJE	October 7, 2010
First Posted Date ICMJE	March 22, 2011
Last Update Posted Date	October 11, 2016
Study Start Date ICMJE	March 2011
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 21, 2011)	To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation [ Time Frame: at day 28 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01320384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 21, 2011)	mechanical ventilation-free to day 28 [ Time Frame: 28 days ]; ICU morbidity [ Time Frame: at day 28 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)
Official Title ICMJE	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)
Brief 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 : 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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Acute Lung Injury; Acute Respiratory Failure
Intervention ICMJE	Other: O2 conventional standard low flow therapy; Device: O2-HFN : high flow nasal oxygen therapy 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%.; Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation 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 Arms	Active Comparator: O2 conventional : standard low flow therapy in order to obtain a SpO2>92% Intervention: Other: O2 conventional; Experimental: O2-HNF : high flow nasal oxygen therapy set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%. Intervention: Device: O2-HFN : high flow nasal oxygen therapy; Experimental: O2-HFN/NPPV cycling of NIV and O2-HDN Intervention: Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Publications *	Frat 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, Béduneau G, Delétage-Métreau 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 10, 2016)	313
Original Estimated Enrollment ICMJE; (submitted: March 21, 2011)	300
Actual Study Completion Date	July 2013
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Hypoxemic and no hypercapnic acute respiratory failure :; severe dyspnea at rest with a respiratory rate >25 breaths/min; PaO2/FiO2 <300; PaCO2 <45 mmHg, Exclusion Criteria: 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 90 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01320384
Other Study ID Numbers ICMJE	FLORALI
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Poitiers university hospital, CHU Poitiers
Study Sponsor ICMJE	Poitiers University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Poitiers University Hospital
Verification Date	October 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP