Prostate CancerNCT03031613
Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
A study testing PEEP group and ZEEP group in people with Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP) Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PEEP group and ZEEP group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Nov 2017
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing robotic-assisted laparoscopic radical prostatectomy
Who cannot join
- History of opthalmic disease or surgery
- History of brain disease or surgery
- Known ICP elevation
- Known IOP elevation
- Presence of lung bullae on chest x-ray
- History of pneumothorax
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Medical College Gangnam Severance Hospital
Seoul
Dong Woo Han, MD., Ph.D., 82220193529
About this study
Official title: Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)
Read the detailed description
Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.
- Conditions
- Prostate Cancer
- Being tested
- PEEP group, ZEEP group
- Keywords
- intraocular pressure, intracerebral pressure
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP groupProcedure or surgery
Application of 5cmH20 positive end expiratory pressure
ZEEP groupProcedure or surgery
No application of positive end expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| PEEP group | Experimental | Application of 5 cmH2O PEEP during mechanical ventilation Receives: Procedure: PEEP group |
| ZEEP group | Active comparator | No application of PEEP during mechanical ventilation Receives: Procedure: ZEEP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
Measured: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
ICP
ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound
Measured: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Woo Han, Gangnam Severance Hospital
- Investigators
- Dong Woo Han, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031613
- Sponsor's protocol ID
- 3-2016-0263
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03031613
- Acronym / sponsor ID
- 3-2016-0263
- Conditions
- Prostate Cancer
- Keywords
- intraocular pressure, intracerebral pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Jan 2017 (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.
To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)
Detailed description
Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP group | Experimental | Procedure: PEEP groupApplication of 5 cmH2O PEEP during mechanical ventilation |
| ZEEP group | Active comparator | Procedure: ZEEP groupNo application of PEEP during mechanical ventilation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing robotic-assisted laparoscopic radical prostatectomy
Key exclusion criteria (6 listed)
- History of opthalmic disease or surgery
- History of brain disease or surgery
- Known ICP elevation
- Known IOP elevation
- Presence of lung bullae on chest x-ray
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 |
|---|---|---|
| PEEP groupApplication of 5cmH20 positive end expiratory pressure | Procedure or surgery | PEEP group |
| ZEEP groupNo application of positive end expiratory pressure | Procedure or surgery | ZEEP group |
Primary outcome
IOP
Time frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
ICP
Time frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Dong Woo Han principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP group and ZEEP group in people with Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. 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 South Korea. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Woo Han (02-2019-3529, hanesth@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min). 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 25 Jan 2017.