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

This study has been completed.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01320384
First received: October 7, 2010
Last updated: May 12, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 314
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320384

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

No publications provided

Responsible Party: Poitiers university hospital, CHU Poitiers
ClinicalTrials.gov Identifier: NCT01320384     History of Changes
Other Study ID Numbers: FLORALI
Study First Received: October 7, 2010
Last Updated: May 12, 2014
Health Authority: France : Agence Française de sécurité sanitaire des produits de santé

Keywords provided by Poitiers University Hospital:
ALI

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

ClinicalTrials.gov processed this record on September 16, 2014