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

Acute Respiratory Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320384
• Other study ID #: FLORALI
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2010
• Last updated: October 10, 2016
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Failure
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Wounds and Injuries

Intervention

Other:
• O2 conventional
standard low flow therapy

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%.
• 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.

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation		at day 28	No
Secondary	mechanical ventilation-free to day 28		28 days	No
Secondary	ICU morbidity		at day 28	No