A Phase 2/3 interventional study of O2 conventional and O2-HFN : high flow nasal oxygen therapy in Acute Lung Injury and Acute Respiratory Failure, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by Poitiers University Hospital · Phase 2/3, Interventional, and Treatment
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 :
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 313 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
in order to obtain a SpO2\>92%
Other: O2 conventional
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 \>92%.
Device: O2-HFN : high flow nasal oxygen therapy
cycling of NIV and O2-HDN
Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
standard low flow 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%.
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.
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Time frame: at day 28
mechanical ventilation-free to day 28
Time frame: 28 days
ICU morbidity
Time frame: at day 28
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Poitiers University Hospital