CholecystitisNCT06224868
Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter
A study testing insufflation and desufflation in people with Cholecystitis, run by Baskent University.
Trial summary
Laparoscopic surgeries are now more popular because of the advantages such as shorter hospital stay, minimal scar. In order to perform laparoscopic surgery, pneumoperitoneum should be initiated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis
- What is being tested?
- insufflation and desufflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 15 Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18- 65 aged all female and male volunteers
Who cannot join
- acute or chronic eye diseases,
- uncontrolled hypertension,
- asthma
- known lung disease,
- body mass index (BMI) over 35 kg/m2,
- devices using bulbs with known intracranial charging,
- who refuse to participate in care
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter (ONSD), Diaphragmatic Thickness ,and Lung Score in Laparoscopic Surgery Patients
Laparoscopic surgeries are now more popular because of the advantages such as shorter hospital stay, minimal scar. In order to perform laparoscopic surgery, pneumoperitoneum should be initiated. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes
Read the detailed description
Laparoscopic surgeries are now becoming increasingly common compared to traditional laparotomies, as they have advantages such as more minimal scarring, shorter hospital stay, fewer complications, and early mobilization. In these surgeries, pneumoperitoneum provided with carbon dioxide (CO2) has many effects on the cardiovascular, pulmonary, renal, metabolic and cerebral systems. Pulmonary compliance and functional residual capacity decrease due to pnemoperitoneum, ventilation/perfusion mismatch occurs, and as a result, hypoxemia may occur. A minimum of 4-6 cm H20 positive end-expiratory pressure (PEEP) should be applied to all intubated patients under general anesthesia to reduce postoperative pulmonary complications (especially atelectasis) and prevent ventilation/perfusion mismatch and hypoxemia. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. When ICP is > 20 mm Hg, measuring the optic nerve sheath diameter (ONSD) between 5.2 and 5.9 mm has a sensitivity of 74-95% and a specificity of 74-100%. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes (trendelenburg/reverse trendelenburg position, pneumoperitoneum , PEEP in mechanical ventilation).
- Conditions
- Cholecystitis
- Being tested
- insufflation, desufflation
- Keywords
- laparoscopic surgery, pneumoperitoneum, optic nerve sheath diameter
- Medical subject headings
- Cholecystitis, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insufflationOther
Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures.
desufflationOther
Laparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| PEEP 0 | Active comparator | After the patient is intubated, PEEP 0 will be set on the mechanical ventilator. Receives: Other: insufflation; Other: desufflation |
| PEEP 5 | Active comparator | After the patient is intubated, PEEP 5 will be set on the mechanical ventilator. Receives: Other: insufflation; Other: desufflation |
| PEEP 10 | Active comparator | After the patient is intubated, PEEP 10 will be set on the mechanical ventilator. Receives: Other: insufflation; Other: desufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values
comparison of diameter of optic nerve sheath (ONSD) for different PEEP values with ultrasonography (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)
Measured: Intraoperatively
comparison of diaphragmatic thickness with USG for different PEEP values
comparison of diaphragmatic thickness with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)
Measured: Intraoperatively
comparison of lung ultrasound scores (LUS) via USG for different PEEP values
comparison of lung scores with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O). This measurement calculated by
LUS assigns 0 points to A lines or < 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations with a score ranging from 0 (normal lungs) to 36 (worst case scenario)
Measured: Intraoperatively
Secondary outcomes (3)
comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.
comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures. ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum.
Normal intraabdominal pressure is 5-7 mmHg. Pneumoperitoneum is achieved by insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg.
Measured: Intraoperatively
comparison of diaphragmatic thickness with USG with different intraabdominal pressures.
comparison of diaphragmatic thickness with USG in different intraabdominal pressures ( insufflation and desufflation) Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum.
Measured: Intraoperatively
comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.
comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures. ( insufflation and desufflation)
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: PEEP 0 Group 2: PEEP 5 Group 3: PEEP 10
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Nemika Gökdemir, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224868
- Sponsor's protocol ID
- KA 23/230
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different PEEP Values With USG on Optic Nerve Sheath Diameter (ONSD), Diaphragmatic Thickness ,and Lung Score in Laparoscopic Surgery Patients
- ClinicalTrials.gov ID
- NCT06224868
- Acronym / sponsor ID
- KA 23/230
- Conditions
- Cholecystitis
- Keywords
- laparoscopic surgery, pneumoperitoneum, optic nerve sheath diameter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
Laparoscopic surgeries are now more popular because of the advantages such as shorter hospital stay, minimal scar. In order to perform laparoscopic surgery, pneumoperitoneum should be initiated. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes
Detailed description
Laparoscopic surgeries are now becoming increasingly common compared to traditional laparotomies, as they have advantages such as more minimal scarring, shorter hospital stay, fewer complications, and early mobilization. In these surgeries, pneumoperitoneum provided with carbon dioxide (CO2) has many effects on the cardiovascular, pulmonary, renal, metabolic and cerebral systems. Pulmonary compliance and functional residual capacity decrease due to pnemoperitoneum, ventilation/perfusion mismatch occurs, and as a result, hypoxemia may occur. A minimum of 4-6 cm H20 positive end-expiratory pressure (PEEP) should be applied to all intubated patients under general anesthesia to reduce postoperative pulmonary complications (especially atelectasis) and prevent ventilation/perfusion mismatch and hypoxemia. The optic nerve sheath is an extension of the dura mater and the subarachnoid space is continuous with the intracranial subarachnoid space. Therefore, non-invasive monitoring of the increase in intracranial pressure (ICP) can be achieved by measuring the optic nerve and sheath diameter with ultrasound. When ICP is > 20 mm Hg, measuring the optic nerve sheath diameter (ONSD) between 5.2 and 5.9 mm has a sensitivity of 74-95% and a specificity of 74-100%. Since ONSD measurement with ultrasound is an easily applicable technique, it is useful in monitoring intracranial pressure changes based on the optic nerve diameter during intraoperative changes (trendelenburg/reverse trendelenburg position, pneumoperitoneum , PEEP in mechanical ventilation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Group 1: PEEP 0 Group 2: PEEP 5 Group 3: PEEP 10
| Arm | Type | Receives |
|---|---|---|
| PEEP 0 | Active comparator | Other: insufflation, Other: desufflationAfter the patient is intubated, PEEP 0 will be set on the mechanical ventilator. |
| PEEP 5 | Active comparator | Other: insufflation, Other: desufflationAfter the patient is intubated, PEEP 5 will be set on the mechanical ventilator. |
| PEEP 10 | Active comparator | Other: insufflation, Other: desufflationAfter the patient is intubated, PEEP 10 will be set on the mechanical ventilator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18- 65 aged all female and male volunteers
Key exclusion criteria (7 listed)
- acute or chronic eye diseases,
- uncontrolled hypertension,
- asthma
- known lung disease,
- body mass index (BMI) over 35 kg/m2,
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 |
|---|---|---|
| insufflationLaparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg (Normal values are 5-7 mmHg) it is aimed to monitor optic sheat nerve diameter and lung ultrasound score changes with different intraabdominal pressures. | Other | PEEP 0, PEEP 10, PEEP 5 |
| desufflationLaparoscopic surgery begins with intraabdominal placement of the insufflation needle or trochar, followed by carbon dioxide (CO2) insufflation of the abdominal cavity to an intraabdominal pressure (IAP) of 12 to 15 mm Hg. When the surgery is completed, the trochars are removed and intra-abdominal pressure is returned to normal which is 5-7 mmHg. | Other | PEEP 0, PEEP 10, PEEP 5 |
Primary outcome
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values
Time frame: Intraoperatively
comparison of diameter of optic nerve sheath (ONSD) for different PEEP values with ultrasonography (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)
comparison of diaphragmatic thickness with USG for different PEEP values
Time frame: Intraoperatively
comparison of diaphragmatic thickness with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O)
comparison of lung ultrasound scores (LUS) via USG for different PEEP values
Time frame: Intraoperatively
comparison of lung scores with USG for different PEEP values (Group 1: 0 cmH2O, Group 2: 5 cmH2O, Group 3: PEEP 10 cmH2O). This measurement calculated by LUS assigns 0 points to A lines or < 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations with a score ranging from 0 (normal lungs) to 36 (worst case scenario)
3 secondary outcomes
comparison of diameter of optic nerve sheath via USG with different intraabdominal pressures.
Time frame: Intraoperatively
comparison of diaphragmatic thickness with USG with different intraabdominal pressures.
Time frame: Intraoperatively
comparison of lung ultrasound scores (LUS) via USG with different intraabdominal pressures.
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing insufflation and desufflation in people with Cholecystitis, run by Baskent University.
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 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begum N Gokdemir (03122036868, begokdemir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of diameter of optic nerve sheath with ultrasonography (USG) for different PEEP values (time frame: Intraoperatively). The study lists 3 primary outcomes in all. 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 25 Jan 2024.