Cerebral IschemiaNCT01436812
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
A study testing zero end-expiratory pressure and positive end expiratory pressure in people with Cerebral Ischemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- zero end-expiratory pressure and positive end expiratory pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jun 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position
Who cannot join
- Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Reveiw Board of Gachon Univerity Gil Hospital
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).
Read the detailed description
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.
- Conditions
- Cerebral Ischemia
- Being tested
- zero end-expiratory pressure, positive end expiratory pressure
- Keywords
- cerebral oxymetry, laparoscopy, PEEP
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zero end-expiratory pressureProcedure or surgery
Also called ZEEP
positive end expiratory pressure 0 cm H2O during peumoperitoneum
positive end expiratory pressureProcedure or surgery
Also called ZEEP
PEEP 0 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| zero end-expiratory pressure | Placebo comparator | not applying PEEP during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, Receives: Procedure: positive end expiratory pressure |
| positive end expiratory pressure | Active comparator | applying PEEP 10cmH2O during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, Receives: Procedure: zero end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral ischemia
induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record
Measured: change from baseline in rSO2 at every events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
- Investigators
- Hyun Jeong Kwak, MD.PhD, Study chair, Gachon University Gil Medical CenterYoun Yi Jo, MD.PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436812
- Sponsor's protocol ID
- GIRBA2551
- Other IDs
- GIRBA2551
- Status last verified
- Aug 2013
- First submitted
- 15 Sep 2011
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Reveiw Board of Gachon Univerity Gil Hospital
- ClinicalTrials.gov ID
- NCT01436812
- Acronym / sponsor ID
- GIRBA2551
- Conditions
- Cerebral Ischemia
- Keywords
- cerebral oxymetry, laparoscopy, PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Sep 2011 (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 hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).
Detailed description
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zero end-expiratory pressure | Placebo comparator | Procedure: positive end expiratory pressurenot applying PEEP during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, |
| positive end expiratory pressure | Active comparator | Procedure: zero end-expiratory pressureapplying PEEP 10cmH2O during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position
Key exclusion criteria (1 listed)
- Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.
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 |
|---|---|---|
| zero end-expiratory pressureAlso: ZEEPpositive end expiratory pressure 0 cm H2O during peumoperitoneum | Procedure or surgery | positive end expiratory pressure |
| positive end expiratory pressureAlso: ZEEPPEEP 0 cmH2O | Procedure or surgery | zero end-expiratory pressure |
Primary outcome
cerebral ischemia
Time frame: change from baseline in rSO2 at every events
induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record
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 12 Aug 2013.
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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.
Hyun Jeong Kwak, MD.PhD study chair
Gachon University Gil Medical Center
Youn Yi Jo, MD.PhD principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zero end-expiratory pressure and positive end expiratory pressure in people with Cerebral Ischemia, run by Gachon University Gil Medical Center 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 1 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 12 Aug 2013. 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. 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?
cerebral ischemia (time frame: change from baseline in rSO2 at every events). 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 12 Aug 2013.