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

NCT07494240 | Not Yet Recruiting DMC

• 1 other identifier: FMBSUREC/06012026/Radwan
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Dynamic Lung Compliance

Outcome Measures

Primary Outcomes (1)

• 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

  Recorded at T3 (10 minutes after pneumoperitoneum cessation).

Secondary Outcomes (3)

• 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).

• Driving Pressure

  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)

  Within 48 hours postoperatively.

Study Arms (2)

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.

Other: incremental peep

fixed peep

NO INTERVENTION

Fixed PEEP = 5 cmH₂O through surgery

Interventions

incremental peep OTHER

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

incremental peep

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Central Study Contacts

Eman G Radwan, master

CONTACT

+201278555771; eman_gamal1@hotmail.com

Samaa A Rashwan, Professor

CONTACT

+201270159125; samaarashwan1971@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)