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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320384
First Posted: March 22, 2011
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Poitiers University Hospital
  Purpose

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).

Condition Intervention Phase
Acute Lung Injury Acute Respiratory Failure Other: O2 conventional Device: O2-HFN : high flow nasal oxygen therapy Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation [ Time Frame: at day 28 ]

Secondary Outcome Measures:
  • mechanical ventilation-free to day 28 [ Time Frame: 28 days ]
  • ICU morbidity [ Time Frame: at day 28 ]

Enrollment: 313
Study Start Date: March 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: O2 conventional : standard low flow therapy
in order to obtain a SpO2>92%
Other: O2 conventional
standard low flow therapy
Experimental: O2-HNF : high flow nasal oxygen therapy
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.
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%.
Experimental: O2-HFN/NPPV
cycling of NIV and O2-HDN
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320384


Locations
France
Poitiers University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Poitiers university hospital, CHU Poitiers
ClinicalTrials.gov Identifier: NCT01320384     History of Changes
Other Study ID Numbers: FLORALI
First Submitted: October 7, 2010
First Posted: March 22, 2011
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Poitiers University Hospital:
ALI

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Insufficiency
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Thoracic Injuries