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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)

Primary Purpose

Acute Lung Injury, Acute Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
O2 conventional
O2-HFN : high flow nasal oxygen therapy
O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring ALI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Poitiers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

O2 conventional : standard low flow therapy

O2-HNF : high flow nasal oxygen therapy

O2-HFN/NPPV

Arm Description

in order to obtain a SpO2>92%

set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.

cycling of NIV and O2-HDN

Outcomes

Primary Outcome Measures

To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

Secondary Outcome Measures

mechanical ventilation-free to day 28
ICU morbidity

Full Information

First Posted
October 7, 2010
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01320384
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)
Acronym
FLORALI
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 : conventional oxygen therapy (O2 conventional) high flow nasal oxygen therapy (O2-HFN) association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Respiratory Failure
Keywords
ALI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O2 conventional : standard low flow therapy
Arm Type
Active Comparator
Arm Description
in order to obtain a SpO2>92%
Arm Title
O2-HNF : high flow nasal oxygen therapy
Arm Type
Experimental
Arm Description
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.
Arm Title
O2-HFN/NPPV
Arm Type
Experimental
Arm Description
cycling of NIV and O2-HDN
Intervention Type
Other
Intervention Name(s)
O2 conventional
Intervention Description
standard low flow therapy
Intervention Type
Device
Intervention Name(s)
O2-HFN : high flow nasal oxygen therapy
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Time Frame
at day 28
Secondary Outcome Measure Information:
Title
mechanical ventilation-free to day 28
Time Frame
28 days
Title
ICU morbidity
Time Frame
at day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25981908
Citation
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, Beduneau G, Deletage-Metreau 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.
Results Reference
derived

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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)

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