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| Name | Class |
|---|---|
| Prostate Center North West Department of Urology and Pediatric Urology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olympus UHI-3 | Sham Comparator | patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system |
|
| AirSeal | Active Comparator | patients are treated with the AirSeal-CO2-insufflator and trocar-system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSeal | Device | 100 patients are treated with the AirSeal insufflation and trocar system |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Reuter, PhD MD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Study Director |
| Alexander März, MD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Principal Investigator |
| Günter Lippert, MD | Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany . | Principal Investigator |
| Alexander Haese, PhD MD | Martini Clinic, Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany. | Principal Investigator |
| Jörn Witt, MD | Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau | Gronau | 48599 | Germany | |||
| Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg |
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| Olympus UHI-3 |
| Device |
100 patients are treated with a conventional insufflation and trocar system |
|
| 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 |
| Hamburg |
| 20246 |
| Germany |