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NCT02506270 Clinical Trial

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

Mechanical Ventilation Pressure High Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02506270
Other study ID # 1/307.14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date June 2015

Study information
Verified date August 2018
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Mechanical Ventilation Pressure High

Intervention

Device:
• Airseal Trocar
28 patients are treated with the AirSeal insufflation and trocar system
• conventional trocar
28 patients are treated with a conventional insufflation and trocar system

Locations
Country Name City State
Italy Regina Elena CI Rome

Sponsors (1)
Lead Sponsor Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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