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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A1069-34 | Other Identifier | ANSM( France) |
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Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FULLY CLOSED-LOOP VENTILATION | Experimental | IntelliVent-ASV automatic mode |
|
| Conventional modes ventilation | Active Comparator | Conventional modes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION | Device |
| ||
| Conventionals Modes |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of manual adjustments | Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV) | participants are followed until they no longer need ventilation, up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| sedation duration, | participants are followed until they no longer need ventilation, up to 10 days | |
| ventilation parameters | participants are followed until they no longer need ventilation, up to 10 days |
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Inclusion criteria:
- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Toulon | Paca | 83056 | France | ||
| Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo |
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| Device |
|
| Sedation doses | participants are followed until they no longer need ventilation, up to 10 days |
| Duration of invasive ventilation | participants are followed until they no longer need ventilation, up to 10 days |
| ICU Mortality | participants are followed until they no longer need ventilation, up to 10 days |
| 28 days mortality | participants are followed until they no longer need ventilation, up to 10 days |
| Pavia |
| Lombardy |
| 27100 |
| Italy |