Mechanical Ventilation Pressure High
Conditions
Brief summary
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.
Interventions
DEVICEAirseal Trocar
28 patients are treated with the AirSeal insufflation and trocar system
DEVICEconventional trocar
28 patients are treated with a conventional insufflation and trocar system
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of dynamic compliance during surgery | 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 | the variations of dynamic compliance during surgery are measured by mechanical ventilator and are expressed in ml/cmH2O |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of peripheral oxygen saturation during surgery | 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 | the variations of peripheral oxygen saturation during surgery are measured by multiparameter patient monitor and are expressed in % |
| change of Peak Pressure during surgery | 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 | the variations of peak pressure during surgery are measured by mechanical ventilator and are expressed in cmH2O |
Countries
Italy
Outcome results
None listed