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

Phase 2

Completed

• Conditions: Acute Lung Injury; Acute Respiratory Failure
• Interventions: Other: O2 conventional

• Registration Number: NCT01320384
• Lead Sponsor: Poitiers University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
O2 conventional : standard low flow therapy	O2 conventional	in order to obtain a SpO2\>92%

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICU morbidity	at day 28
mechanical ventilation-free to day 28	28 days

Trial Locations

Locations (1)

Poitiers University Hospital; 🇫🇷 Poitiers, France