Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients

Comparison of Stepwise PEEP vs Sustained Inflation Recruitment Maneuvers on Postoperative Oxygenation and Atelectasis in Bariatric Surgery Patients

Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate; Recruitment
• Intervention / Treatment: Procedure: sustained inflation recruitement; Procedure: Stepwise PEEP

Detailed Description

In the SI group:, the anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator will be switched to manual mode, and the airway pressure-limiting valve will be set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O was achieved. This pressure was maintained continuously for 30 seconds. Following the maneuver, mechanical ventilation was resumed with positive end-expiratory pressure (PEEP) back to 5 cmho In the IP group:, alveolar recruitment will be performed as follows: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O (so peep will reach 20), held for 30 s , then PEEP will be gradually reduced at intervals of 5 cmH2O down to 5 cmH2O, when initial volume control ventilation will be resumed. In the incremental PEEP group, PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O was achieved, after which mechanical ventilation was resumed with maintenance PEEP. The total duration of the recruitment maneuver was approximately 60-90 seconds.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amr fouad, M.D; Phone Number: 01225674370; Email: amr_foud@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Amr Fouad, M.D; Phone Number: +201225674370; Email: amr_foud@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Anesthesiologists (ASA) physical status II, of either sex Age ≥18 y.
2. Undergoing laparoscopic bariatric surgeries; sleeve gastrectomy, mini gastric bypass
3. BMI (35-60)

Exclusion Criteria:

1. Pre-existing severe pulmonary disease
2. Baseline hypoxemia SpO₂ <92% on room air
3. History of barotrauma
4. Previous pneumothorax
5. Known pulmonary bullae or emphysematous blebs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group SI; receive 30 cmH₂O sustained inflation for 30seconds	Procedure: sustained inflation recruitement; anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator was switched to manual mode, and the airway pressure-limiting valve was set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O
Active Comparator: group IP; receive PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O	Procedure: Stepwise PEEP; : ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative lung aeration	limited-zone lung ultrasound scoring system	in the post-anesthesia care unit 15 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative oxygenation	SpO₂	in the post-anesthesia care unit 15 minutes after extubation
Oxygen requirement in PACU	to maintain SpO₂ ≥94%.	in the post-anesthesia care unit 15 minutes after extubation

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMASU R58/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No