Mechanical Ventilation Pressure HighNCT02506270
Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy
A study testing Airseal Trocar and conventional trocar in people with Mechanical Ventilation Pressure High, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Pressure High
- What is being tested?
- Airseal Trocar and conventional trocar
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Jun 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for robotic-assisted Radical Cystectomy
- Written informed consent
- - ≥ 18 years of age
Who cannot join
- Patients who refuse participating in the study
- ejection fraction < 40%
- history of retinal vascular occlusion and ischaemic optic neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.
- Conditions
- Mechanical Ventilation Pressure High
- Being tested
- Airseal Trocar, conventional trocar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airseal TrocarDevice
Also called trocar valveless
28 patients are treated with the AirSeal insufflation and trocar system
conventional trocarDevice
28 patients are treated with a conventional insufflation and trocar system
| Study group | Role | What they receive |
|---|---|---|
| AirSeal Trocar valveless | Active comparator | patients are treated with the AirSeal-CO2-insufflator and trocar-system Receives: Device: Airseal Trocar |
| Conventional trocar | Sham comparator | patients are treated with a conventional insufflation and trocar system Receives: Device: conventional trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of dynamic compliance during surgery
the variations of dynamic compliance during surgery are measured by mechanical ventilator and are expressed in ml/cmH2O
Measured: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position
Secondary outcomes (2)
change of peripheral oxygen saturation during surgery
the variations of peripheral oxygen saturation during surgery are measured by multiparameter patient monitor and are expressed in %
Measured: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position,1h after extubation
change of Peak Pressure during surgery
the variations of peak pressure during surgery are measured by mechanical ventilator and are expressed in cmH2O
Measured: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning 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 posted23 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation Pressure HighStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506270
- Sponsor's protocol ID
- 1/307.14
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
Publications
Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
PubMed 20888033
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02506270
- Acronym / sponsor ID
- 1/307.14
- Conditions
- Mechanical Ventilation Pressure High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jul 2015 (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 the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AirSeal Trocar valveless | Active comparator | Device: Airseal Trocarpatients are treated with the AirSeal-CO2-insufflator and trocar-system |
| Conventional trocar | Sham comparator | Device: conventional trocarpatients are treated with a conventional insufflation and trocar system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for robotic-assisted Radical Cystectomy
- Written informed consent
- - ≥ 18 years of age
Key exclusion criteria (3 listed)
- Patients who refuse participating in the study
- ejection fraction < 40%
- history of retinal vascular occlusion and ischaemic optic neuropathy
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 |
|---|---|---|
| Airseal TrocarAlso: trocar valveless28 patients are treated with the AirSeal insufflation and trocar system | Device | AirSeal Trocar valveless |
| conventional trocar28 patients are treated with a conventional insufflation and trocar system | Device | Conventional trocar |
Primary outcome
change of dynamic compliance during surgery
Time frame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position
the variations of dynamic compliance during surgery are measured by mechanical ventilator and are expressed in ml/cmH2O
2 secondary outcomes
change of peripheral oxygen saturation during surgery
Time frame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position,1h after extubation
change of Peak Pressure during surgery
Time frame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning 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 31 Aug 2018.
- Background: PubMed 20888033Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airseal Trocar and conventional trocar in people with Mechanical Ventilation Pressure High, run by Regina Elena Cancer Institute at 1 site in Italy.
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 3 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
change of dynamic compliance during surgery (time frame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506270, which also lists 1 linked publication.
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 31 Aug 2018.