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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| device FreeO2 | Experimental | Automatic adjustment of oxygen |
|
| Manual oxygenation | Active Comparator | Manual adjustment of oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device FreeO2 v2.0 | Device |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erwan L'HER | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Hotel Dieux de Levis | Lévis | Quebec | Canada | |||
| Institut universitaire de Cardiologie et de Pneumologie de Québec |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28729473 | Derived | L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
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| Device FreeO2 v2.0 | Device |
|
|
| 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 |
| Québec |
| Quebec |
| Canada |
| HIA Clermont Tonnerre | Brest | 29200 | France |
| Brest, University Hospital | Brest | France |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |