Automatic Administration of Oxygen During Respiratory Distress

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Respiratory Distress Syndrome, Hypoxemia

Intervention / Treatment
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* Device: Device FreeO2 v2.0
* Device: Device FreeO2 v2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%. Inclusion within a time less than two hours after the start of the oxygen at the emergency. Patient consent,or a close. Exclusion Criteria: Necessity of an oxygen flow exceeds 15 L / min to maintain a SpO2 higher than 92%. Criteria of gravity justifying immediately a different technique of ventilatory support: Disturbance of consciousness with a Glasgow Coma Score ≤ 12 Serious ventricular rhythm disorders Hemodynamic instability (SBP <80mmHg or recourse to vasopressors) Cardiac or respiratory arrest pH < 7.35 and PaCO2 > 55 mm Hg Necessity of a urgent surgery, or coronary revascularization Age <18 years Pregnant women, lactating Patient not relevant Unavailability of the prototype FreeO2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device FreeO2<br>Automatic adjustment of oxygen | Device: Device FreeO2 v2.0<br>* Automatic adjustment of oxygen through the Free O2 device. FreeO2 device in mode medical data collecting(SpO2,EtCO2...).<br>|
| Active Comparator: Manual oxygenation<br>Manual adjustment of oxygen | Device: Device FreeO2 v2.0<br>* Manual adjustment of oxygen without the assistance of the FreeO2 device. Only FreeO2 device in mode medical data collecting(SpO2,EtCO2...).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 hours or 1 hour after after cessation of oxygenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures |  | 3 days max | 
| Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%). |  | 3 hours or 1 hour after after cessation of oxygenation | 
| Maintaining EtCO2 in a selected area |  | 3 hours or 1 hour after after cessation of oxygenation | 
| Oxygen consumption measured at the end of administration |  | 3 hours or 1 hour after after cessation of oxygenation | 
| Duration of administration during hospitalization |  | 28 days max | 
| Number of complications related to the administration of oxygen |  | 28 days max | 
| Frequency of use of invasive or noninvasive ventilation during hospitalization. |  | 28 days max |