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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Pressure High
• Interventions: Device: conventional trocar; Device: Airseal Trocar

• Registration Number: NCT02506270
• Lead Sponsor: Regina Elena Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional trocar	conventional trocar	patients are treated with a conventional insufflation and trocar system
AirSeal Trocar valveless	Airseal Trocar	patients are treated with the AirSeal-CO2-insufflator and trocar-system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Regina Elena CI; 🇮🇹 Rome, Italy