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NCT Number: NCT01320384

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 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).

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Key information

Conditions

Acute Lung Injury Acute Respiratory Failure Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Poitiers University Hospital

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

O2 conventional

Other

standard low flow therapy

O2-HFN : high flow nasal oxygen therapy

Device

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%.

O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation

Device

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 outcomes

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

    Time frame: at day 28

Secondary outcomes

  1. mechanical ventilation-free to day 28

    Time frame: 28 days

  2. ICU morbidity

    Time frame: at day 28

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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)

Acronym: FLORALI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2011
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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