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Not yet recruiting NCT07494240

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

No phase Interventional Dynamic Lung Compliance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: incremental peep.
Who it may be relevant to
Registry conditions: Dynamic Lung Compliance. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other incremental peep
    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

Primary outcome measures

  • dynamic pulmonary compliance [Time frame: Recorded at T3 (10 minutes after pneumoperitoneum cessation).]
Secondary outcome measures (3)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Beni-Suef University Hospital — Banī Suwayf

Identifiers

NCT: NCT07494240 · FMBSUREC/06012026/Radwan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗