Other Surgical ProceduresNCT02516566
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy
A study testing PEEP in people with Other Surgical Procedures, run by Asan Medical Center.
Trial summary
The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy
Who cannot join
- Patients who have cerebrovascular disease or history of cerebrovascular disease
- Patients who are younger than 20 years
About this study
Official title: Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy
The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
Read the detailed description
Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
- Conditions
- Other Surgical Procedures
- Being tested
- PEEP
- Keywords
- Positive end-expiratory pressure ventilation, Optic nerve sheath diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
Mechanical ventilation with PEEP 8 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| PEEP group | Experimental | Mechanical ventilation with PEEP 8 cmH2O Receives: Other: PEEP |
| No PEEP group | No intervention | Mechanical ventilation with no PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Measured: intraoperative
Secondary outcomes (4)
Peak airway pressure
Measured: intraoperative
Arterial blood pressure
Measured: intraoperative
Heart rate
Measured: intraoperative
Arterial carbon dioxide tension
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionNov 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 Other Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516566
- Sponsor's protocol ID
- AsanMC
- Status last verified
- Nov 2015
- First submitted
- 3 Aug 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.
PubMed 28107408
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT02516566
- Acronym / sponsor ID
- AsanMC
- Conditions
- Other Surgical Procedures
- Keywords
- Positive end-expiratory pressure ventilation, Optic nerve sheath diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Aug 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 investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
Detailed description
Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP group | Experimental | Other: PEEPMechanical ventilation with PEEP 8 cmH2O |
| No PEEP group | No intervention | –Mechanical ventilation with no PEEP |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy
Key exclusion criteria (2 listed)
- Patients who have cerebrovascular disease or history of cerebrovascular disease
- Patients who are younger than 20 years
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 |
|---|---|---|
| PEEPMechanical ventilation with PEEP 8 cmH2O | Other | PEEP group |
Primary outcome
Optic nerve sheath diameter
Time frame: intraoperative
4 secondary outcomes
Peak airway pressure
Time frame: intraoperative
Arterial blood pressure
Time frame: intraoperative
Heart rate
Time frame: intraoperative
Arterial carbon dioxide tension
Time frame: intraoperative
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 2 Dec 2015.
- Derived from this study: PubMed 28107408Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.
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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.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Other Surgical Procedures, run by Asan Medical Center.
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 2 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Optic nerve sheath diameter (time frame: intraoperative). 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 NCT02516566, 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 2 Dec 2015.