Lung Function After Robot-assisted Radical Prostate Ectomy

Investigation of the Possible Advantages of the AirSeal-system Compared to Conventional CO2 Insufflation Systems in Terms of Lung Function and Hemodynamics in Robot-assisted Laparoscopic Radical Prostate Ectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02066246

Enrollment

192

Registered

2014-02-19

Start date

2013-08-31

Completion date

2014-09-30

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Function

Keywords

laparoscopic robot-assisted surgery, in steep trendelenburg position

Brief summary

The aim of our study is to investigate if the use of the AirSeal insufflation system impairs the lung function of patients less than a conventional system in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung function before and after surgery. As a second purpose of the study, in a subgroup, we investigate the influence of the gas insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography technique.

Interventions

DEVICEAirSeal

100 patients are treated with the AirSeal insufflation and trocar system

DEVICEOlympus UHI-3

100 patients are treated with a conventional insufflation and trocar system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled for RALP * Written informed consent * ≥ 18 years of age

Exclusion criteria

* Age under 18 years * Patients who refuse participating in the study * Obstructive airway disease (COPD and Asthma) * Postoperative admission to an intensive or intermediate care unit * Patients who do not speak German or English

Design outcomes

Primary

Measure	Time frame
forced vital capacity (FVC)	before operation, 1, 24, 120 hours after surgery
forced expiratory volume in one second (FEV1)	before operation, 1, 24, 120 hours after surgery

Secondary

Measure	Time frame	Description
ventilation parameters	after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position	peak pressure, positive end-expiratory pressure, end-tidal CO2, respiratory rate are recorded during surgery
hemodynamic parameters	after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position	global end diastolic volume (GEDV), stoke volume variation (SVV); cardiac index (CI), extravascular lung water index (EVLWI)
electric impedance tomography	after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026