Brain IschemialapaPEEPNCT01443962
The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy
A study testing PEEP and ZEEP in people with Brain Ischemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2) Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- PEEP and ZEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Mar 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II,
- 20-65 year,
- patient who undergoing laparoscopic cholecystectomy
Who cannot join
- cerebrovascular disease,
- coronary artery disease,
- morbid obesity (BMI > 30)
- propofol allergy,
- addictive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)
Read the detailed description
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.
- Conditions
- Brain Ischemia
- Being tested
- PEEP, ZEEP
- Keywords
- laparoscopic cholecystectomy, PEEP, rSO2
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
Also called PEEP 0
applying PEEP 0 cmH2O during pneumoperitoneum continuously
ZEEPOther
Also called PEEP 10
applying PEEP 10 cmH2O during pneumoperitoneum continuously
| Study group | Role | What they receive |
|---|---|---|
| Zero positive end expiratory pressure | Experimental | Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period Receives: Other: PEEP |
| positive end expiratory pressure | Active comparator | applying PEEP 10 cmH2O during pneumoperitoneum continuously Receives: Other: ZEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in regional brain oxygen saturation
FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs
Measured: from baseline record rSO2 every 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jeong Kwak, Gachon University Gil Medical Center
- Investigators
- Kyung Chon Lee, M.D., Ph.D, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443962
- Sponsor's protocol ID
- GIRBA 2568
- Acronym
- lapaPEEP
- Status last verified
- Feb 2013
- First submitted
- 27 Sep 2011
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01443962
- Acronym / sponsor ID
- lapaPEEP / GIRBA 2568
- Conditions
- Brain Ischemia
- Keywords
- laparoscopic cholecystectomy, PEEP, rSO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 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.
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)
Detailed description
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero positive end expiratory pressure | Experimental | Other: PEEPNumber: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period |
| positive end expiratory pressure | Active comparator | Other: ZEEPapplying PEEP 10 cmH2O during pneumoperitoneum continuously |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II,
- 20-65 year,
- patient who undergoing laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- cerebrovascular disease,
- coronary artery disease,
- morbid obesity (BMI > 30)
- propofol allergy,
- addictive
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 |
|---|---|---|
| PEEPAlso: PEEP 0applying PEEP 0 cmH2O during pneumoperitoneum continuously | Other | Zero positive end expiratory pressure |
| ZEEPAlso: PEEP 10applying PEEP 10 cmH2O during pneumoperitoneum continuously | Other | positive end expiratory pressure |
Primary outcome
change in regional brain oxygen saturation
Time frame: from baseline record rSO2 every 10 minutes
FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs
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 5 Feb 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.
Kyung Chon Lee, M.D., Ph.D 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 PEEP and ZEEP in people with Brain 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 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 5 Feb 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. 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 in regional brain oxygen saturation (time frame: from baseline record rSO2 every 10 minutes). 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 5 Feb 2013.