Dynamic Lung CompliancePEEPNCT07494240
Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Laparoscopic Sleeve Gastrectomy
A study testing incremental peep in people with Dynamic Lung Compliance, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this prospective intervention study is to determine whether individualized positive end expiratory pressure (PEEP) titration targeting the minimum Driving pressure (ΔP) during LGS operation improves intraoperative pulmonary dynamic compliance (Cdyn), oxygenation, post operative pulmonary complication… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dynamic Lung Compliance
- What is being tested?
- incremental peep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 35 -40kg·m-²
- ASA II-III
- Elective primary laparoscopic sleeve gastrectomy
Who cannot join
- Patient refusing consent
- ASA IV patients.
- Sever pulmonary disease
- Sever obstructive sleep apnea (OSA)
- Hepatic or cardic or renal imparment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62511
Eman G Radwan, master, +201278555771, eman_gamal1@hotmail.com
Samaa A Rashwan, Professor, +201270159125, samaarashwan1971@gmail.com
About this study
Official title: Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Patients Undergoing Laparoscopic Sleeve Gastrectomy
The goal of this prospective intervention study is to determine whether individualized positive end expiratory pressure (PEEP) titration targeting the minimum Driving pressure (ΔP) during LGS operation improves intraoperative pulmonary dynamic compliance (Cdyn), oxygenation, post operative pulmonary complication (PPCS) Participants will be assigned to two group (incremental - fixed )peep group Researchers will compare the two group to see if peep titration improve lung compliance, lung mechanics intraopertive and PPCS
Read the detailed description
Obesity (BMI \ge 30 kg/m^2) significantly increases the risk of atelectasis and respiratory dysfunction under anesthesia. During Laparoscopic Sleeve Gastrectomy (LSG), the combination of pneumoperitoneum and the Trendelenburg position further impairs lung compliance. Standard lung-protective strategies often use a fixed PEEP, which may be insufficient for obese patients or cause hemodynamic instability if set too high.
Fixed PEEP (usually 5 cmH_2O) does not account for individual variations in chest wall mechanics during laparoscopy.
This prospective, randomized, double-blind study involving 46 patients (20-60 years old, BMI 35-40 kg/m^2).
The Intervention
- Control Group: Receives a fixed PEEP of 5 cmH_ throughout the procedure.
- Intervention Group: Receives individualized PEEP titration. After a recruitment maneuver, PEEP is adjusted (from 3 to 12 cmH_2O) to identify the level that achieves the minimum Driving Pressure . This optimal PEEP is then maintained for the surgery.
Key Outcomes
- Primary: Dynamic pulmonary compliance measured 10 minutes after pneumoperitoneum cessation (T3).
- Secondary: Oxygenation (PaO_2/FiO_2 ratio), driving pressure levels, postoperative pulmonary complications (PPCs) within 48 hours, and length of hospital stay.
- Conditions
- Dynamic Lung Compliance
- Being tested
- incremental peep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incremental peepOther
PEEP will be gradually increased by 1 cmH2O starting from the lowest PEEP allowed by the anesthesia machine (3 cmH2O) to 12 cmH2O, and each PEEP level will be maintained for 10 respiratory cycles and the driving pressure values will be recorded. When driving pressure increased with increasing PEEP, downward PEEP titration will be per- formed until the minimum driving pressure appears
| Study group | Role | What they receive |
|---|---|---|
| incremental peep | Active comparator | after the pneumo- peritoneum- anti Trendelenburg position is established and RM is performed. PEEP will be gradually increased by 1 cmH2O starting from the lowest PEEP allowed by the anesthesia machine (3 cmH2O) to 12 cmH2O, and each PEEP level will be maintained for 10 respiratory cycles and the driving pressure values will be recorded. When driving pressure increased with increasing PEEP, downward PEEP titration will be per- formed until the minimum driving pressure appears. this optimal individualized PEEP will be maintained throughout the procedure. Receives: Other: incremental peep |
| fixed peep | No intervention | Fixed PEEP = 5 cmH₂O through surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic pulmonary compliance
Measurement of the lung's ability to stretch and expand during mechanical ventilation, calculated 10 minutes after the cessation of pneumoperitoneum. This measures the impact of individualized PEEP versus fixed PEEP on respiratory mechanics after the main surgical stressor is removed
Measured: Recorded at T3 (10 minutes after pneumoperitoneum cessation).
Secondary outcomes (3)
Oxygenation Ratio (PaO_2/FiO_2)
Assessed via arterial blood gas analysis to evaluate gas exchange efficiency.
Measured: Recorded at T0(10 minutes after tracheal intubation), , T2(1 hour after pneumoperitoneum establishment), and T4 (15 minutes after extubation).
Driving Pressure
Calculated as Plateau pressure minus PEEP.
Measured: Recorded at T0 (10 minutes after intubation), T1 (10 minutes after pneumoperitoneum), T2 (1 hour after pneumoperitoneum), and T3 (10 minutes after pneumoperitoneum cessation).
Postoperative Pulmonary Complications (PPCs)
Incidence of hypoxia, bronchospasm, or chest infections (cough, fever, expectoration).
Measured: Within 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Lung ComplianceStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blinded, parallel-group study. Patients are randomly assigned in a 1:1 ratio to either the intervention or control group using a computer-generated sequence. * Intervention Group (DP Group): Following a recruitment maneuver, PEEP is titrated incrementally (by 1 cmH) to identify and maintain the minimum Driving Pressure . * Control Group (Fixed Group): Patients receive a standard fixed PEEP of 5 cmH\_2O throughout the procedure. * Standardization: Both groups receive volume-controlled ventilation (V\_T 8 ml/kg IBW) and identical anesthetic protocols. * Objective: To compare the effects of individualized versus fixed PEEP on dynamic lung compliance (C\_{dyn}) and oxygenation (PaO\_2/FiO\_2) during laparoscopic sleeve gastrectomy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Gamal Fathy Radwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494240
- Sponsor's protocol ID
- FMBSUREC/06012026/Radwan
- Acronym
- PEEP
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07494240
- Acronym / sponsor ID
- PEEP / FMBSUREC/06012026/Radwan
- Conditions
- Dynamic Lung Compliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
The goal of this prospective intervention study is to determine whether individualized positive end expiratory pressure (PEEP) titration targeting the minimum Driving pressure (ΔP) during LGS operation improves intraoperative pulmonary dynamic compliance (Cdyn), oxygenation, post operative pulmonary complication (PPCS) Participants will be assigned to two group (incremental - fixed )peep group Researchers will compare the two group to see if peep titration improve lung compliance, lung mechanics intraopertive and PPCS
Detailed description
Obesity (BMI \ge 30 kg/m^2) significantly increases the risk of atelectasis and respiratory dysfunction under anesthesia. During Laparoscopic Sleeve Gastrectomy (LSG), the combination of pneumoperitoneum and the Trendelenburg position further impairs lung compliance. Standard lung-protective strategies often use a fixed PEEP, which may be insufficient for obese patients or cause hemodynamic instability if set too high.
Fixed PEEP (usually 5 cmH_2O) does not account for individual variations in chest wall mechanics during laparoscopy.
This prospective, randomized, double-blind study involving 46 patients (20-60 years old, BMI 35-40 kg/m^2).
The Intervention
- Control Group: Receives a fixed PEEP of 5 cmH_ throughout the procedure.
- Intervention Group: Receives individualized PEEP titration. After a recruitment maneuver, PEEP is adjusted (from 3 to 12 cmH_2O) to identify the level that achieves the minimum Driving Pressure . This optimal PEEP is then maintained for the surgery.
Key Outcomes
- Primary: Dynamic pulmonary compliance measured 10 minutes after pneumoperitoneum cessation (T3).
- Secondary: Oxygenation (PaO_2/FiO_2 ratio), driving pressure levels, postoperative pulmonary complications (PPCs) within 48 hours, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blinded, parallel-group study. Patients are randomly assigned in a 1:1 ratio to either the intervention or control group using a computer-generated sequence. * Intervention Group (DP Group): Following a recruitment maneuver, PEEP is titrated incrementally (by 1 cmH) to identify and maintain the minimum Driving Pressure . * Control Group (Fixed Group): Patients receive a standard fixed PEEP of 5 cmH_2O throughout the procedure. * Standardization: Both groups receive volume-controlled ventilation (V_T 8 ml/kg IBW) and identical anesthetic protocols. * Objective: To compare the effects of individualized versus fixed PEEP on dynamic lung compliance (C_{dyn}) and oxygenation (PaO_2/FiO_2) during laparoscopic sleeve gastrectomy.
| Arm | Type | Receives |
|---|---|---|
| incremental peep | Active comparator | Other: incremental peepafter the pneumo- peritoneum- anti Trendelenburg position is established and RM is performed. PEEP will be gradually increased by 1 cmH2O starting from the lowest PEEP allowed by the anesthesia machine (3 cmH2O) to 12 cmH2O, and each PEEP level will be maintained for 10 respiratory cycles and the driving pressure values will be recorded. When driving pressure increased with increasing PEEP, downward PEEP titration will be per- formed until the minimum driving pressure appears. this optimal individualized PEEP will be maintained throughout the procedure. |
| fixed peep | No intervention | –Fixed PEEP = 5 cmH₂O through surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 35 -40kg·m-²
- ASA II-III
- Elective primary laparoscopic sleeve gastrectomy
Key exclusion criteria (5 listed)
- Patient refusing consent
- ASA IV patients.
- Sever pulmonary disease
- Sever obstructive sleep apnea (OSA)
- Hepatic or cardic or renal imparment
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 |
|---|---|---|
| incremental peepPEEP will be gradually increased by 1 cmH2O starting from the lowest PEEP allowed by the anesthesia machine (3 cmH2O) to 12 cmH2O, and each PEEP level will be maintained for 10 respiratory cycles and the driving pressure values will be recorded. When driving pressure increased with increasing PEEP, downward PEEP titration will be per- formed until the minimum driving pressure appears | Other | incremental peep |
Primary outcome
dynamic pulmonary compliance
Time frame: Recorded at T3 (10 minutes after pneumoperitoneum cessation).
Measurement of the lung's ability to stretch and expand during mechanical ventilation, calculated 10 minutes after the cessation of pneumoperitoneum. This measures the impact of individualized PEEP versus fixed PEEP on respiratory mechanics after the main surgical stressor is removed
3 secondary outcomes
Oxygenation Ratio (PaO_2/FiO_2)
Time frame: Recorded at T0(10 minutes after tracheal intubation), , T2(1 hour after pneumoperitoneum establishment), and T4 (15 minutes after extubation).
Driving Pressure
Time frame: Recorded at T0 (10 minutes after intubation), T1 (10 minutes after pneumoperitoneum), T2 (1 hour after pneumoperitoneum), and T3 (10 minutes after pneumoperitoneum cessation).
Postoperative Pulmonary Complications (PPCs)
Time frame: Within 48 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incremental peep in people with Dynamic Lung Compliance, run by Beni-Suef University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 27 Mar 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman G Radwan, master (+201278555771, eman_gamal1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic pulmonary compliance (time frame: Recorded at T3 (10 minutes after pneumoperitoneum cessation).). 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 27 Mar 2026.