CClinicalTrials.gg
Not yet recruitingNCT07494240PEEPUpdated Mar 27, 2026

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

An interventional study of incremental peep in Dynamic Lung Compliance, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Dynamic Lung Compliance
03

In context

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient refusing consent
  • ASA IV patients.
  • Sever pulmonary disease
  • Sever obstructive sleep apnea (OSA)
  • Hepatic or cardic or renal imparment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    incremental peep

    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

  • No intervention
    fixed peep

    Fixed PEEP = 5 cmH₂O through surgery

Interventions

  • Otherincremental 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

06

What researchers measure

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

    Time frame: Recorded at T3 (10 minutes after pneumoperitoneum cessation).

Secondary outcomes

  1. Oxygenation Ratio (PaO_2/FiO_2)

    Assessed via arterial blood gas analysis to evaluate gas exchange efficiency.

    Time frame: Recorded at T0(10 minutes after tracheal intubation), , T2(1 hour after pneumoperitoneum establishment), and T4 (15 minutes after extubation).

  2. Driving Pressure

    Calculated as Plateau pressure minus PEEP.

    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).

  3. Postoperative Pulmonary Complications (PPCs)

    Incidence of hypoxia, bronchospasm, or chest infections (cough, fever, expectoration).

    Time frame: Within 48 hours postoperatively.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07494240
Lead sponsor
Beni-Suef University
Responsible party
Eman Gamal Fathy Radwan (Assistant lecturer, Beni-Suef University) — Principal investigator
First posted
Mar 27, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Sep 15, 2027 (estimated)
Completion
Oct 15, 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Eman G Radwan, master
Contact
eman_gamal1@hotmail.com
+201278555771
Samaa A Rashwan, Professor
Contact
samaarashwan1971@gmail.com
+201270159125

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion