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Completed

NCT Number: NCT02506270

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

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.

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Key information

Conditions

Mechanical Ventilation Pressure High

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regina Elena CI

Rome, 00144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airseal Trocar

Device

28 patients are treated with the AirSeal insufflation and trocar system

Other names: trocar valveless

conventional trocar

Device

28 patients are treated with a conventional insufflation and trocar system

Primary outcomes

  1. change of dynamic compliance during surgery

    Time frame: 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 outcomes

  1. change of peripheral oxygen saturation during surgery

    Time frame: 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 %

  2. change of Peak Pressure during surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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