Lung Function After Robot-assisted Radical Prostate Ectomy

N/ACompletedNCT02066246

Universitätsklinikum Hamburg-Eppendorf192 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

192

Conditions

Lung Function

Interventions

AirSealDEVICE

100 patients are treated with the AirSeal insufflation and trocar system

Olympus UHI-3DEVICE

100 patients are treated with a conventional insufflation and trocar system

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau

Gronau, Germany

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Hamburg, Germany

Outcomes

Primary Outcomes

forced vital capacity (FVC)

Time frame: before operation, 1, 24, 120 hours after surgery

forced expiratory volume in one second (FEV1)

Time frame: before operation, 1, 24, 120 hours after surgery

Secondary Outcomes

ventilation parameters

peak pressure, positive end-expiratory pressure, end-tidal CO2, respiratory rate are recorded during surgery

Time frame: 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)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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