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

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)

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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