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

B

Beni-Suef University

Status

Not yet enrolling

Conditions

Dynamic Lung Compliance

Treatments

Other: incremental peep

Study type

Interventional

Funder types

Other

Identifiers

NCT07494240
FMBSUREC/06012026/Radwan

Details and patient eligibility

About

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

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

incremental peep
Active Comparator group
Description:
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.
Treatment:
Other: incremental peep
fixed peep
No Intervention group
Description:
Fixed PEEP = 5 cmH₂O through surgery

Trial contacts and locations

1

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Central trial contact

Samaa A Rashwan, Professor; Eman G Radwan, master

Data sourced from clinicaltrials.gov

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