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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01320384
First received: October 7, 2010
Last updated: March 21, 2011
Last verified: March 2011

October 7, 2010
March 21, 2011
March 2011
March 2013   (final data collection date for primary outcome measure)
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01320384 on ClinicalTrials.gov Archive Site
  • mechanical ventilation-free to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ICU morbidity [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)
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 :

  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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lung Injury
  • Acute Respiratory Failure
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2013
March 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 90 Years
No
Contact: Jean-Pierre FRAT, MD 33 (0) 5 49 44 40 07
France
 
NCT01320384
FLORALI
Yes
Poitiers university hospital, CHU Poitiers
Poitiers University Hospital
Not Provided
Not Provided
Poitiers University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP