Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients

NCT07525232 | Recruiting

• 1 other identifier: FMASU R58/2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recruitment; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Postoperative lung aeration

  limited-zone lung ultrasound scoring system

  in the post-anesthesia care unit 15 minutes after extubation

Secondary Outcomes (2)

• Postoperative oxygenation

  in the post-anesthesia care unit 15 minutes after extubation

• Oxygen requirement in PACU

  in the post-anesthesia care unit 15 minutes after extubation

Study Arms (2)

group SI

ACTIVE COMPARATOR

receive 30 cmH₂O sustained inflation for 30seconds

Procedure: sustained inflation recruitement

group IP

ACTIVE COMPARATOR

receive PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O

Procedure: Stepwise PEEP

Interventions

sustained inflation recruitement PROCEDURE

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

group SI

Stepwise PEEP PROCEDURE

: 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

group IP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pre-existing severe pulmonary disease
• Baseline hypoxemia SpO₂ \<92% on room air
• History of barotrauma
• Previous pneumothorax
• Known pulmonary bullae or emphysematous blebs

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

amr fouad, M.D

CONTACT

01225674370; amr_foud@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)