Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62511, Egypt
Location contact
Eman G Radwan, master
CONTACT
Samaa A Rashwan, Professor
CONTACT
Not Yet Recruiting
NCT Number: NCT07494240
Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in 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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
20 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
incremental peep
OtherPEEP 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
Primary outcomes
-
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
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).
Assessed via arterial blood gas analysis to evaluate gas exchange efficiency.
-
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).
Calculated as Plateau pressure minus PEEP.
-
Postoperative Pulmonary Complications (PPCs)
Time frame: Within 48 hours postoperatively.
Incidence of hypoxia, bronchospasm, or chest infections (cough, fever, expectoration).
Study contacts
Contact information is provided by the study sponsor or research team.
Eman G Radwan, master
CONTACT
Samaa A Rashwan, Professor
CONTACT
Sponsors and collaborators
Lead sponsor
Beni-Suef University
Other
Registry information
Official study title
Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Acronym: PEEP
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 27, 2026
- Registry last updated
- Mar 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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