Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedAugust 31, 2018
August 1, 2018
9 months
July 17, 2015
August 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
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
Study Arms (2)
AirSeal Trocar valveless
ACTIVE COMPARATORpatients are treated with the AirSeal-CO2-insufflator and trocar-system
Conventional trocar
SHAM COMPARATORpatients are treated with a conventional insufflation and trocar system
Interventions
28 patients are treated with the AirSeal insufflation and trocar system
28 patients are treated with a conventional insufflation and trocar system
Eligibility Criteria
You may qualify if:
- Patients scheduled for robotic-assisted Radical Cystectomy
- Written informed consent
- \- ≥ 18 years of age
You may not qualify if:
- Patients who refuse participating in the study
- ejection fraction \< 40%
- history of retinal vascular occlusion and ischaemic optic neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regina Elena CI
Rome, 00144, Italy
Related Publications (1)
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.
PMID: 20888033BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Anaestesiology and Critical Care
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 23, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 31, 2018
Record last verified: 2018-08