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

August 29, 2018 updated by: Ester Forastiere, Regina Elena Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Regina Elena CI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AirSeal Trocar valveless
patients are treated with the AirSeal-CO2-insufflator and trocar-system
Device: Airseal Trocar
28 patients are treated with the AirSeal insufflation and trocar system
Other Names:
  • trocar valveless
Sham Comparator: Conventional trocar
patients are treated with a conventional insufflation and trocar system
Device: conventional trocar
28 patients are treated with a conventional insufflation and trocar system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 %
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1/307.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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