NCT02027181

Automatic Administration of Oxygen During Respiratory Distress

Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Respiratory Distress Syndrome
• Hypoxemia

Interventions

Type	Name	Description
DEVICE	Device FreeO2 v2.0	* Automatic adjustment of oxygen through the "Free O2" device. * "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
DEVICE	Device FreeO2 v2.0	* Manual adjustment of oxygen without the assistance of the "FreeO2" device. * Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-01-06
• Last updated: 2014-10-31

Locations

4 sites across 2 countries: Canada, France