PneumoperitoneumNCT05992636
Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
An observational study of Pneumoperitoneum, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- pneumoperitoneum insufflation (flow) rate
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2021to 20 Jun 2022
- 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
- Adult, Older adult
Study population: After the approval of the Ethics Committee, a total of 69 (sixty) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients with low insufflation flow (10 lt/min), and 35 (thirty-five) patients in high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
Who may be able to join
- elective laparoscopic cholecystectomy were planned,
- ASA I-III,
- 18-65 years old
Who cannot join
- Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
- Uncontrolled diabetes
- Uncontrolled hypertension
- Coagulopathy,
- Cirrhosis and/or peritonitis,
- Asthma and/or respiratory diseases e.g. COPD,
Show all 10Show fewer
- Morbid obesity,
- Patients with severe organ failure,
- Emergency cases,
- Cases converted to laparotomic cholecystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy
Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.
Read the detailed description
After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.
The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)
- Conditions
- Pneumoperitoneum
- Being tested
- pneumoperitoneum insufflation (flow) rate
- Keywords
- laparoscopic cholecystectomy, Near Infrared Spectroscopy (NIRS)
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumoperitoneum insufflation (flow) rateProcedure or surgery
Patiens who initiate with low insufflation flow (10 lt/min)
Patiens who initiate with high insufflation flow (40 lt/min)
| Study group | Role | What they receive |
|---|---|---|
| low insufflation flow (10 lt/min) | Patiens who perform pneumoperitoneum with low insufflation flow (10 lt/min) Receives: Procedure: pneumoperitoneum insufflation (flow) rate | |
| high insufflation flow (40 lt/min) | Patiens who perform pneumoperitoneum with high insufflation flow (40 lt/min) Receives: Procedure: pneumoperitoneum insufflation (flow) rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between insufflation flow rate and cerebral desaturation (rSO2)
With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS).
The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )
Measured: 8 months
Secondary outcomes (3)
the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)
Relationship between insufflation flow rate and end-tidal carbon dioxide value variation of the patients according to basal and before-pnömoperitoneum end-tidal carbon dioxide levels (mmHg) was determined with capnographic measurements.
Measured: 8 months
the relationship between insufflation flow rate and heart rate value variation (beats per minute)
Relationship between insufflation flow rate and heart rate value variation of the patients according to basal and before-pnömoperitoneum heart rate levels was determined with pulse monitoring.
Measured: 8 months
the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)
Relationship between insufflation flow rate and systolic, diastolic and mean arterial pressure (mmHg) values variation of the patients according to basal and before-pnömoperitoneum systolic, diastolic and mean arterial pressure levels were determined with non-invasive blood pressure measurements.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start19 May 2021
- Primary completion23 Apr 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies 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
- 69 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDAT SAYLAN, Karadeniz Technical University
- Investigators
- KIVANÇ ÖNCÜ, M.D., Study chair, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992636
- Sponsor's protocol ID
- Karadeniz Teknik Üniversitesi
- Status last verified
- Aug 2023
- First submitted
- 12 Nov 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05992636
- Acronym / sponsor ID
- Karadeniz Teknik Üniversitesi
- Conditions
- Pneumoperitoneum
- Keywords
- laparoscopic cholecystectomy, Near Infrared Spectroscopy (NIRS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 15 Aug 2023 (actual)
- 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.
Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.
Detailed description
After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.
The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low insufflation flow (10 lt/min) | – | Procedure: pneumoperitoneum insufflation (flow) ratePatiens who perform pneumoperitoneum with low insufflation flow (10 lt/min) |
| high insufflation flow (40 lt/min) | – | Procedure: pneumoperitoneum insufflation (flow) ratePatiens who perform pneumoperitoneum with high insufflation flow (40 lt/min) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- After the approval of the Ethics Committee, a total of 69 (sixty) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients with low insufflation flow (10 lt/min), and 35 (thirty-five) patients in high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
Key inclusion criteria (3 listed)
- elective laparoscopic cholecystectomy were planned,
- ASA I-III,
- 18-65 years old
Key exclusion criteria (10 listed)
- Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
- Uncontrolled diabetes
- Uncontrolled hypertension
- Coagulopathy,
- Cirrhosis and/or peritonitis,
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 |
|---|---|---|
| pneumoperitoneum insufflation (flow) ratePatiens who initiate with low insufflation flow (10 lt/min) Patiens who initiate with high insufflation flow (40 lt/min) | Procedure or surgery | high insufflation flow (40 lt/min), low insufflation flow (10 lt/min) |
Primary outcome
the relationship between insufflation flow rate and cerebral desaturation (rSO2)
Time frame: 8 months
With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS). The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )
3 secondary outcomes
the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)
Time frame: 8 months
the relationship between insufflation flow rate and heart rate value variation (beats per minute)
Time frame: 8 months
the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)
Time frame: 8 months
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 15 Aug 2023.
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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.
KIVANÇ ÖNCÜ, M.D. study chair
Karadeniz Technical University
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 Pneumoperitoneum, run by Karadeniz Technical University 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 3 inclusion and 10 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 15 Aug 2023. 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?
the relationship between insufflation flow rate and cerebral desaturation (rSO2) (time frame: 8 months). 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 15 Aug 2023.