Lung FunctionNCT02066246
Lung Function After Robot-assisted Radical Prostate Ectomy
A study testing AirSeal and Olympus UHI-3 in people with Lung Function, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lung Function
- What is being tested?
- AirSeal and Olympus UHI-3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for RALP
- Written informed consent
- ≥ 18 years of age
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau
Gronau, 48599
Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Hamburg, 20246
About this study
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
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.
- Conditions
- Lung Function
- Being tested
- AirSeal, Olympus UHI-3
- Keywords
- laparoscopic robot-assisted surgery, in steep trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSealDevice
100 patients are treated with the AirSeal insufflation and trocar system
Olympus UHI-3Device
100 patients are treated with a conventional insufflation and trocar system
| Study group | Role | What they receive |
|---|---|---|
| Olympus UHI-3 | Sham comparator | patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system Receives: Device: Olympus UHI-3 |
| AirSeal | Active comparator | patients are treated with the AirSeal-CO2-insufflator and trocar-system Receives: Device: AirSeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity (FVC)
Measured: before operation, 1, 24, 120 hours after surgery
forced expiratory volume in one second (FEV1)
Measured: before operation, 1, 24, 120 hours after surgery
Secondary outcomes (3)
ventilation parameters
peak pressure, positive end-expiratory pressure, end-tidal CO2, respiratory rate are recorded during surgery
Measured: 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
global end diastolic volume (GEDV), stoke volume variation (SVV); cardiac index (CI), extravascular lung water index (EVLWI)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Center North West Department of Urology and Pediatric Urology
- Responsible party
- Sponsor
- Investigators
- Daniel A Reuter, PhD MD, Study director, Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of HamburgAlexander März, MD, Principal investigator, Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of HamburgGünter Lippert, MD, Principal investigator, Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany .Alexander Haese, PhD MD, Principal investigator, Martini Clinic, Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.Jörn Witt, MD, Principal investigator, Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066246
- Sponsor's protocol ID
- ANA-UKE-PV4374
- Status last verified
- Oct 2014
- First submitted
- 22 Jan 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02066246
- Acronym / sponsor ID
- ANA-UKE-PV4374
- Conditions
- Lung Function
- Keywords
- laparoscopic robot-assisted surgery, in steep trendelenburg position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Prostate Center North West Department of Urology and Pediatric Urology
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olympus UHI-3 | Sham comparator | Device: Olympus UHI-3patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system |
| AirSeal | Active comparator | Device: AirSealpatients are treated with the AirSeal-CO2-insufflator and trocar-system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for RALP
- Written informed consent
- ≥ 18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirSeal100 patients are treated with the AirSeal insufflation and trocar system | Device | AirSeal |
| Olympus UHI-3100 patients are treated with a conventional insufflation and trocar system | Device | Olympus UHI-3 |
Primary outcome
forced vital capacity (FVC)
Time frame: 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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Reuter, PhD MD study director
Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Alexander März, MD principal investigator
Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Günter Lippert, MD principal investigator
Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany .
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSeal and Olympus UHI-3 in people with Lung Function, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (FVC) (time frame: before operation, 1, 24, 120 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.