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

R

Regina Elena Cancer Institute

Status

Completed

Conditions

Mechanical Ventilation Pressure High

Treatments

Device: conventional trocar
Device: Airseal Trocar

Study type

Interventional

Funder types

Other

Identifiers

NCT02506270
1/307.14

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

AirSeal Trocar valveless
Active Comparator group
Description:
patients are treated with the AirSeal-CO2-insufflator and trocar-system
Treatment:
Device: Airseal Trocar
Conventional trocar
Sham Comparator group
Description:
patients are treated with a conventional insufflation and trocar system
Treatment:
Device: conventional trocar

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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