Lung Function After Robot-assisted Radical Prostate Ectomy

Not Applicable

Completed

• Conditions: Lung Function
• Interventions: Device: Olympus UHI-3; Device: AirSeal

• Registration Number: NCT02066246
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olympus UHI-3	Olympus UHI-3	patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system
AirSeal	AirSeal	patients are treated with the AirSeal-CO2-insufflator and trocar-system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg; 🇩🇪 Hamburg, Germany

Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau; 🇩🇪 Gronau, Germany