NCT02066246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

January 22, 2014

Last Update Submit

October 8, 2014

Conditions

Lung Function

Keywords

laparoscopic robot-assisted surgeryin steep trendelenburg position

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Olympus UHI-3

SHAM COMPARATOR

patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system

Device: Olympus UHI-3

AirSeal

ACTIVE COMPARATOR

patients are treated with the AirSeal-CO2-insufflator and trocar-system

Device: AirSeal

Interventions

AirSealDEVICE

100 patients are treated with the AirSeal insufflation and trocar system

AirSeal
Olympus UHI-3DEVICE

100 patients are treated with a conventional insufflation and trocar system

Olympus UHI-3

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for RALP
  • Written informed consent
  • ≥ 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau

Gronau, 48599, Germany

Location

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

Hamburg, 20246, Germany

Location

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

February 19, 2014

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DE(2)