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)

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

Tracking Information

• First Submitted Date: October 7, 2010
• First Posted Date: March 22, 2011
• Last Update Posted Date: October 11, 2016
• Study Start Date: March 2011
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01320384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Lung Injury
• Acute Respiratory Failure

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 10, 2016): 313
• Original Estimated Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01320384
• Other Study ID Numbers: 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: Poitiers University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Poitiers University Hospital
• Verification Date: October 2016