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| ID | Type | Description | Link |
|---|---|---|---|
| CHRU de Brest | Registry Identifier | RB14-060 |
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The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.
The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeO2 v2.2 active | Experimental | Automatic Oxygen Administration |
|
| FreeO2 v2.2 with manual oxygenation | Active Comparator | Manual Oxygen Administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeO2 v2.2 active | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent in the target zone of oxygen saturation | The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| nursing workload | nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures | 3 days |
| Time spent in a area of severe desaturation (SpO2 <85%) | Time spent in a area of severe desaturation (SpO2 <85%) evaluated by freeO2 device |
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Inclusion Criteria:
Randomization Criteria:
Admission in post-anesthesia care unit after major thoracic or abdominal surgery
Randomization and device establishment within a time less than one hour after the endotracheal intubation
Availability of the prototype FreeO2
Absence of criteria of gravity justifying immediately a different technique of ventilatory support:
Necessity of an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
Absence of necessity of a urgent surgery
Oxygen saturation measured by Spo2 sensor
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erwan L'HER | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Laval - Québéc | Québéc | G1V4G5 | Canada | |||
| Brest, University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32855218 | Derived | L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1):2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan. | |
| 30782716 |
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| FreeO2 v2.2 with manual oxygenation | Device |
|
|
| 3 days |
| Time spent in a hyperoxia area (SpO2> 98%). | Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device | 3 days |
| Maintaining EtCO2 in a selected area | Maintaining EtCO2 in a selected area evaluated by freeO2 device | 3 days |
| Oxygen consumption measured at the end of administration | Oxygen consumption measured at the end of administration | 3 days |
| Duration of oxygen administration during hospitalization | Duration of oxygen administration during hospitalization | 3 days |
| Number of complications related to the administration of oxygen | Number of complications related to the administration of oxygen | 28 days max |
| Frequency of use of ventilation (invasive or noninvasive ) | Frequency of use of ventilation (invasive or noninvasive ) | 28 days max |
| Duration of hospitalization | Duration of hospitalization | 28 days max |
| Brest |
| France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| Derived |
| L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833. |