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 recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Poitiers University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Poitiers University Hospital
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01320384
First received: October 7, 2010
Last updated: March 21, 2011
Last verified: March 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lung Injury Acute Respiratory Failure |
Other: O2 conventional Device: O2-HFN : high flow nasal oxygen therapy Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Poitiers University Hospital:
Primary Outcome Measures:
- To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- mechanical ventilation-free to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- ICU morbidity [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: O2 conventional : standard low flow therapy
in order to obtain a SpO2>92%
|
Other: O2 conventional
standard low flow therapy
|
|
Experimental: O2-HNF : high flow nasal oxygen therapy
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.
|
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%.
|
|
Experimental: O2-HFN/NPPV
cycling of NIV and O2-HDN
|
Device: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320384
Contacts
| Contact: Jean-Pierre FRAT, MD | 33 (0) 5 49 44 40 07 |
Locations
| France | |
| Poitiers University Hospital | Recruiting |
| Poitiers, France, 86021 | |
| Principal Investigator: Jean-Pierre FRAT, MD | |
Sponsors and Collaborators
Poitiers University Hospital
More Information
No publications provided
| Responsible Party: | Poitiers university hospital, CHU Poitiers |
| ClinicalTrials.gov Identifier: | NCT01320384 History of Changes |
| Other Study ID Numbers: | FLORALI |
| Study First Received: | October 7, 2010 |
| Last Updated: | March 21, 2011 |
| Health Authority: | France : Agence Française de sécurité sanitaire des produits de santé |
Keywords provided by Poitiers University Hospital:
|
ALI |
Additional relevant MeSH terms:
|
Acute Lung Injury Respiratory Distress Syndrome, Adult Respiratory Insufficiency Lung Injury Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013