Laparoscopic CholecystectomyNIRS AND PEEPNCT02071550
10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices
An observational study of Laparoscopic Cholecystectomy, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor and FORESIGHT and INVOS monitor
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Dec 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic cholecystectomy
Who may be able to join
- ASA(American Society of Anesthesiologist) class I and II
- Patients undergoing laparoscopic cholecystectomy
Who cannot join
- ASA class III and IV
- Morbid obesity
- Emergency cases
- Cases returned to laparotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic
Ankara, 06550
About this study
In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).
Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor, FORESIGHT and INVOS monitor
- Keywords
- laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitorDevice
FORESIGHT and INVOS monitorDevice
| Study group | Role | What they receive |
|---|---|---|
| zero PEEP | Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor Receives: Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor | |
| 10 CM H2O PEEP | Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor Receives: Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cerebral oxymetry during laparoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, aslı demir, Turkiye Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071550
- Sponsor's protocol ID
- 10869
- Acronym
- NIRS AND PEEP
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices
- ClinicalTrials.gov ID
- NCT02071550
- Acronym / sponsor ID
- NIRS AND PEEP / 10869
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2014 (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.
In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).
Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zero PEEP | – | Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor, Device: FORESIGHT and INVOS monitorPatients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor |
| 10 CM H2O PEEP | – | Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor, Device: FORESIGHT and INVOS monitorPatients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- ASA(American Society of Anesthesiologist) class I and II
- Patients undergoing laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- ASA class III and IV
- Morbid obesity
- Emergency cases
- Cases returned to laparotomy
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 |
|---|---|---|
| FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor | Device | 10 CM H2O PEEP, zero PEEP |
| FORESIGHT and INVOS monitor | Device | 10 CM H2O PEEP, zero PEEP |
Primary outcome
change in cerebral oxymetry during laparoscopy
Time frame: 1 day
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 26 Feb 2014.
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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?
An observational study of Laparoscopic Cholecystectomy, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 26 Feb 2014. 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 Turkey (Türkiye). 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 cerebral oxymetry during laparoscopy (time frame: 1 day). 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 26 Feb 2014.