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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320384

Acronym

FLORALI

Enrollment

313

Registered

2011-03-22

Start date

2011-03-31

Completion date

2013-07-31

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Acute Respiratory Failure

Keywords

ALI

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).

Interventions

OTHERO2 conventional

standard low flow therapy

DEVICEO2-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%.

DEVICEO2-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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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)

Design outcomes

Primary

Measure	Time frame
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation	at day 28

Secondary

Measure	Time frame
mechanical ventilation-free to day 28	28 days
ICU morbidity	at day 28

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026