Clinical trial NCT02066246: Lung Function After Robot-assisted Radical Prostate Ectomy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Function
Keywords: laparoscopic robot-assisted surgery
in steep trendelenburg position
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Prostate Center North West Department of Urology and Pediatric Urology
First posted: 2014-02-19
Enrollment: 192
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: forced vital capacity (FVC)
timeFrame: before operation, 1, 24, 120 hours after surgery
measure: forced expiratory volume in one second (FEV1)
timeFrame: before operation, 1, 24, 120 hours after surgery
Secondary outcomes:
measure: ventilation parameters
timeFrame: 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
measure: hemodynamic parameters
timeFrame: 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
measure: electric impedance tomography
timeFrame: 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
Other outcomes:
Locations:
city: Gronau
country: Germany
facility: Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau
city: Hamburg
country: Germany
facility: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Study officials:
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Daniel A Reuter, PhD MD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Alexander März, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany .
name: Günter Lippert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Martini Clinic, Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
name: Alexander Haese, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany
name: Jörn Witt, MD
role: PRINCIPAL_INVESTIGATOR
References: