Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy

Study Overview
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Brief Summary
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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.

Conditions
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Mechanical Ventilation Pressure High

Intervention / Treatment
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* Device: Airseal Trocar
* Device: conventional trocar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for robotic-assisted Radical Cystectomy Written informed consent - ≥ 18 years of age Exclusion Criteria: Patients who refuse participating in the study ejection fraction < 40% history of retinal vascular occlusion and ischaemic optic neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AirSeal Trocar valveless<br>patients are treated with the AirSeal-CO2-insufflator and trocar-system | Device: Airseal Trocar<br>* 28 patients are treated with the AirSeal insufflation and trocar system<br>* Other names: trocar valveless;|
| Sham Comparator: Conventional trocar<br>patients are treated with a conventional insufflation and trocar system | Device: conventional trocar<br>* 28 patients are treated with a conventional insufflation and trocar system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |