Positive End-expiratory Pressure (PEEP)PEEPONNCT06979999
The Effects of Positive End-expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter in Laparoscopic Cholecystectomy
A study testing Positive End-Expiratory Pressure (PEEP) in people with Positive End-expiratory Pressure (PEEP) and Intracranial Pressure, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Positive End-expiratory Pressure (PEEP), Intracranial Pressure, Optic Nerve Sheath Diameter
- What is being tested?
- Positive End-Expiratory Pressure (PEEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2024to 31 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years)
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Signed informed consent
Who cannot join
- resence of acute or chronic eye disease
- Uncontrolled hypertension
- Asthma or known chronic pulmonary disease
- Any neurological disorders
- Body mass index (BMI) > 35 kg/m²
- Use of medications known to affect intracranial pressure
- Refusal to participate after signing informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Training and Research Hospital
Niğde, Niğde Province, 5200
About this study
Official title: The Effects of Positive End-Expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter (ONSD) in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia: A Prospective Interventional Study
This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of approximately 40 adult patients (ASA physical status I-II) will be included following informed consent.
ONSD will be measured using a high-frequency linear ultrasound probe at three predefined intraoperative time points: (T0) 10 minutes after initiation of mechanical ventilation, (T1) 10 minutes after pneumoperitoneum creation, and (T2) 30 minutes after pneumoperitoneum creation. Dynamic lung compliance, peak airway pressure (Ppeak), end-tidal CO₂ (EtCO₂), heart rate, mean arterial pressure, and SpO₂ will also be recorded.
The aim is to assess whether the application of PEEP influences intracranial pressure indicators, particularly ONSD, during laparoscopic procedures. The study may provide valuable insights into the neurophysiological effects of intra-abdominal pressure and mechanical ventilation strategies in surgical patients.
- Conditions
- Positive End-expiratory Pressure (PEEP), Intracranial Pressure, Optic Nerve Sheath Diameter, Mechanical Ventilation
- Being tested
- Positive End-Expiratory Pressure (PEEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive End-Expiratory Pressure (PEEP)Procedure or surgery
Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| PEEP Group | Experimental | This arm includes patients undergoing laparoscopic cholecystectomy under general anesthesia. All participants receive 10 cmH₂O PEEP after pneumoperitoneum creation, and optic nerve sheath diameter (ONSD) is measured intraoperatively at predefined time points. Receives: Procedure: Positive End-Expiratory Pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter (ONSD)
ONSD will be measured via ultrasound at 3 time points during surgery.
Measured: Intraoperative; T0, T1, T2
Secondary outcomes (5)
Change in Peak Airway Pressure (Ppeak)
Peak airway pressure will be measured using the ventilator settings at three predefined intraoperative time points to evaluate respiratory mechanics during PEEP application.
Measured: Intraoperative measurement at T0, T1, and T2
Change in Dynamic Lung Compliance
Dynamic lung compliance will be calculated using the formula: Tidal Volume / (Ppeak - PEEP) and measured at three intraoperative time points.
Measured: Intraoperative measurement at T0, T1, and T2
Change in End-Tidal Carbon Dioxide (EtCO₂)
End-tidal CO₂ levels will be recorded intraoperatively to monitor changes in ventilation efficiency during surgery.
Measured: Intraoperative measurement at T0, T1, and T2
Changes in Heart Rate (HR) and Mean Arterial Pressure (MAP) Time Frame
Heart rate and mean arterial pressure will be recorded at predefined time points to assess hemodynamic stability during surgery.
Measured: Intraoperative measurement at T0, T1, and T2
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation will be monitored continuously and recorded at specified intraoperative time points.
Measured: Intraoperative continuous monitoring and recorded at T0, T1, and T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start23 May 2024
- Primary completion23 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End-expiratory Pressure (PEEP)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval KILBASANLI, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979999
- Sponsor's protocol ID
- 2024/54
- Other IDs
- 2024/54
- Acronym
- PEEPON
- Status last verified
- May 2026
- First submitted
- 29 Apr 2025
- Last updated
- 2 Jun 2026
- Results posted
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positive End-Expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter (ONSD) in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06979999
- Acronym / sponsor ID
- PEEPON / 2024/54
- Conditions
- Positive End-expiratory Pressure (PEEP), Intracranial Pressure, Optic Nerve Sheath Diameter, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 May 2025 (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.
This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of approximately 40 adult patients (ASA physical status I-II) will be included following informed consent.
ONSD will be measured using a high-frequency linear ultrasound probe at three predefined intraoperative time points: (T0) 10 minutes after initiation of mechanical ventilation, (T1) 10 minutes after pneumoperitoneum creation, and (T2) 30 minutes after pneumoperitoneum creation. Dynamic lung compliance, peak airway pressure (Ppeak), end-tidal CO₂ (EtCO₂), heart rate, mean arterial pressure, and SpO₂ will also be recorded.
The aim is to assess whether the application of PEEP influences intracranial pressure indicators, particularly ONSD, during laparoscopic procedures. The study may provide valuable insights into the neurophysiological effects of intra-abdominal pressure and mechanical ventilation strategies in surgical patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEP Group | Experimental | Procedure: Positive End-Expiratory Pressure (PEEP)This arm includes patients undergoing laparoscopic cholecystectomy under general anesthesia. All participants receive 10 cmH₂O PEEP after pneumoperitoneum creation, and optic nerve sheath diameter (ONSD) is measured intraoperatively at predefined time points. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age ≥ 18 years)
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Signed informed consent
Key exclusion criteria (7 listed)
- resence of acute or chronic eye disease
- Uncontrolled hypertension
- Asthma or known chronic pulmonary disease
- Any neurological disorders
- Body mass index (BMI) > 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 |
|---|---|---|
| Positive End-Expiratory Pressure (PEEP)Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy. | Procedure or surgery | PEEP Group |
Primary outcome
Change in Optic Nerve Sheath Diameter (ONSD)
Time frame: Intraoperative; T0, T1, T2
ONSD will be measured via ultrasound at 3 time points during surgery.
5 secondary outcomes
Change in Peak Airway Pressure (Ppeak)
Time frame: Intraoperative measurement at T0, T1, and T2
Change in Dynamic Lung Compliance
Time frame: Intraoperative measurement at T0, T1, and T2
Change in End-Tidal Carbon Dioxide (EtCO₂)
Time frame: Intraoperative measurement at T0, T1, and T2
Changes in Heart Rate (HR) and Mean Arterial Pressure (MAP) Time Frame
Time frame: Intraoperative measurement at T0, T1, and T2
Peripheral Oxygen Saturation (SpO₂)
Time frame: Intraoperative continuous monitoring and recorded at T0, T1, and T2
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 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Positive End-expiratory Pressure (PEEP)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
RecruitingPhase 1/2
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Congenital Heart Disease, Cardiopulmonary Bypass
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?
A study testing Positive End-Expiratory Pressure (PEEP) in people with Positive End-expiratory Pressure (PEEP) and Intracranial Pressure, run by Nigde Omer Halisdemir 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 4 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: finished, as of the sponsor's last update on 2 Jun 2026. 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 Optic Nerve Sheath Diameter (ONSD) (time frame: Intraoperative; T0, T1, T2). 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 2 Jun 2026.