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The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirSeal Trocar valveless | Active Comparator | patients are treated with the AirSeal-CO2-insufflator and trocar-system |
|
| Conventional trocar | Sham Comparator | patients are treated with a conventional insufflation and trocar system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airseal Trocar | Device | 28 patients are treated with the AirSeal insufflation and trocar system |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of dynamic compliance during surgery | the variations of dynamic compliance during surgery are measured by mechanical ventilator and are expressed in ml/cmH2O | 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position |
| Measure | Description | Time Frame |
|---|---|---|
| change of peripheral oxygen saturation during surgery | the variations of peripheral oxygen saturation during surgery are measured by multiparameter patient monitor and are expressed in % | 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position,1h after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Elena CI | Rome | 00144 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20888033 | Background | Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2. |
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| conventional trocar | Device | 28 patients are treated with a conventional insufflation and trocar system |
|
| change of Peak Pressure during surgery | the variations of peak pressure during surgery are measured by mechanical ventilator and are expressed in cmH2O | 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position |