Lung Function After Robot-assisted Radical Prostate Ectomy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Function

Intervention / Treatment
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* Device: AirSeal
* Device: Olympus UHI-3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Olympus UHI-3<br>patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system | Device: Olympus UHI-3<br>* 100 patients are treated with a conventional insufflation and trocar system<br>|
| Active Comparator: AirSeal<br>patients are treated with the AirSeal-CO2-insufflator and trocar-system | Device: AirSeal<br>* 100 patients are treated with the AirSeal insufflation and trocar system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation parameters | peak pressure, positive end-expiratory pressure, end-tidal CO2, respiratory rate are recorded during surgery | 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 | 
| hemodynamic parameters | global end diastolic volume (GEDV), stoke volume variation (SVV); cardiac index (CI), extravascular lung water index (EVLWI) | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic robot-assisted surgery, in steep trendelenburg position