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Completed

NCT Number: NCT02066246

Lung Function After Robot-assisted 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.

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Key information

Conditions

Lung Function

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AirSeal

Device

100 patients are treated with the AirSeal insufflation and trocar system

Olympus UHI-3

Device

100 patients are treated with a conventional insufflation and trocar system

Primary outcomes

  1. forced vital capacity (FVC)

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

  2. forced expiratory volume in one second (FEV1)

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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Prostate Center North West Department of Urology and Pediatric Urology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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