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Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for mechanical ventilation equipment. Disaster may create thousands of critically ill patients requiring mechanical ventilation and may force difficult allocation decisions when demand greatly exceeds supply. Creating a new monitor will only add one more product to the one already used and create confusion for the user. Therefore, the aim is now to develop an independent ventilation module, compatible with the already existing cardiac monitors, which integrates advanced ventilation monitoring functions (mechanical ventilation and RCP). This module could be used by the teams already equipped with multiparametric monitors and be a real added value as the monitoring of the ventilation is critical, especially in emergency situations. Then, it could answer to the clinical need and massively equip every hospital care center in the event of mass casualty incident or viral pandemic. Moreover, this device could be used by emergency teams during daily operations. The aim of this study is to validate a prototype of sensor intended to monitor ventilator parameters of ventilated patients and guide healthcare professionals to provide safe ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prototype of sensor | Experimental | The patient is his own control |
|
| ventilator | Active Comparator | The patient is his own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prototype of sensor | Device | The investigational device is composed of a sensor placed on the respiratory line of the ventilated patients and connected to a ventilation measure unit which records the ventilation parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of patients for whom the insufflated volume measured by the sensor prototype is equivalent to the one measured by the ventilatory monito | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of patients for whom the exhaled volume measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor | 2 hours | |
| Number and proportion of patients for whom the pressure measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25000 | France |
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The patient is his own control
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| 2 hours |
| Number and proportion of patients for whom the flow rate measured by the sensor prototype are equivalent to the one measured by the ventilatory monitor | 2 hours |
| Precision range of the insufflated volume between the sensor prototype and the one measured by the reference ventilator | 2 hours |
| Number and proportion of patients for whom the leak percentage calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the insiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the expiratory time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the pause time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the plateau time calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the respiratory rate calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the mechanical power calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the lung resistance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the lung compliance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and proportion of patients for whom the lung elastance calculated by the sensor prototype are equivalent to the one calculated by the ventilatory monitor ventilator | 2 hours |
| Number and frequency of device deficiencies | 2 hours 30 minutes |
| Number and frequency of adverse events | 2 hours 30 minutes |