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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)

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ClinicalTrials.gov Identifier: NCT01320384
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : October 11, 2016
Sponsor:
Information provided by:
Poitiers University Hospital

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 :

  1. conventional oxygen therapy (O2 conventional)
  2. high flow nasal oxygen therapy (O2-HFN)
  3. 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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