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Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Laparoscopic Sleeve Gastrectomy

Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07494240
Acronym
PEEP
Enrollment
46
Registered
2026-03-27
Start date
2026-04-15
Completion date
2027-10-15
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dynamic Lung Compliance

Brief 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 (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.

Interventions

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

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be randomly assigned to either "Incremental" or "Fixed" in 1:1 ratio according to computer generated random number sequence prepared by an independent statistician who had no involvement in participant recruitment.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* BMI 35 -40kg·m-² * ASA II-III * Elective primary laparoscopic sleeve gastrectomy

Exclusion criteria

* Patient refusing consent * ASA IV patients. * Sever pulmonary disease * Sever obstructive sleep apnea (OSA) * Hepatic or cardic or renal imparment

Design outcomes

Primary

MeasureTime frameDescription
dynamic pulmonary complianceRecorded 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

Secondary

MeasureTime frameDescription
Oxygenation Ratio (PaO_2/FiO_2)Recorded at T0(10 minutes after tracheal intubation), , T2(1 hour after pneumoperitoneum establishment), and T4 (15 minutes after extubation).Assessed via arterial blood gas analysis to evaluate gas exchange efficiency.
Driving PressureRecorded at T0 (10 minutes after intubation), T1 (10 minutes after pneumoperitoneum), T2 (1 hour after pneumoperitoneum), and T3 (10 minutes after pneumoperitoneum cessation).Calculated as Plateau pressure minus PEEP.
Postoperative Pulmonary Complications (PPCs)Within 48 hours postoperatively.Incidence of hypoxia, bronchospasm, or chest infections (cough, fever, expectoration).

Countries

Egypt

Contacts

CONTACTEman G Radwan, master
eman_gamal1@hotmail.com+201278555771
CONTACTSamaa A Rashwan, Professor
samaarashwan1971@gmail.com+201270159125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026