A Phase 1 interventional study of Device FreeO2 v2.0 and Device FreeO2 v2.0 in Acute Respiratory Distress Syndrome and Hypoxemia, sponsored by University Hospital, Brest. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-31.
Sponsored by University Hospital, Brest · Phase 1, Interventional, and Treatment
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 190 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Automatic adjustment of oxygen
Device: Device FreeO2 v2.0
Manual adjustment of oxygen
Device: Device FreeO2 v2.0
* Automatic adjustment of oxygen through the "Free O2" device. * "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
* Manual adjustment of oxygen without the assistance of the "FreeO2" device. * Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
The target zone of oxygen saturation is : SpO2 = 92-96% The "acute phase of treatment" is defined by the 3 first hours of treatment by oxygenation and/or until one hour after the end of this last.
Time frame: 3 hours or 1 hour after after cessation of oxygenation
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time frame: 3 days max
Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Maintaining EtCO2 in a selected area
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Oxygen consumption measured at the end of administration
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Duration of administration during hospitalization
Time frame: 28 days max
Number of complications related to the administration of oxygen
Time frame: 28 days max
Frequency of use of invasive or noninvasive ventilation during hospitalization.
Time frame: 28 days max
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University Hospital, Brest