Lung Function After Robot-assisted Radical Prostate Ectomy

October 8, 2014 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gronau, Germany, 48599
        • Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau
      • Hamburg, Germany, 20246
        • Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Olympus UHI-3
patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system
Device: Olympus UHI-3
100 patients are treated with a conventional insufflation and trocar system
ACTIVE_COMPARATOR: AirSeal
patients are treated with the AirSeal-CO2-insufflator and trocar-system
Device: AirSeal
100 patients are treated with the AirSeal insufflation and trocar system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
forced vital capacity (FVC)
Time Frame: before operation, 1, 24, 120 hours after surgery
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
before operation, 1, 24, 120 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilation parameters
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Prostate Center North West Department of Urology and Pediatric Urology

Investigators

  • Study Director: Daniel A Reuter, PhD 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (ESTIMATE)

February 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANA-UKE-PV4374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Function

Clinical Trials on Olympus UHI-3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe