Lung Function After Robot-assisted Radical Prostate Ectomy

Lung Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066246
• Other study ID #: ANA-UKE-PV4374
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: October 8, 2014
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Function

Intervention

Device:
• AirSeal
100 patients are treated with the AirSeal insufflation and trocar system
• Olympus UHI-3
100 patients are treated with a conventional insufflation and trocar system

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Prostate Center North West Department of Urology and Pediatric Urology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forced vital capacity (FVC)		before operation, 1, 24, 120 hours after surgery	No
Primary	forced expiratory volume in one second (FEV1)		before operation, 1, 24, 120 hours after surgery	No
Secondary	ventilation parameters	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	No
Secondary	hemodynamic parameters	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	No
Secondary	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	No