Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

Not Applicable

Recruiting

• Conditions: Bariatric Surgery Candidate; Mechanical Ventilation Pressure High
• Interventions: Other: titated PEEP to best static compliance

• Registration Number: NCT06168162
• Lead Sponsor: Ain Shams University

Brief Summary

Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.

In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients were eligible for participation if the met the following criteria

  • Age between 18 and 60 years old.
  • Body mass index > 40
  • Laparoscopic bariatric elective surgery under general anesthesia.
  • ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.

Exclusion Criteria

• Previous lung surgery
• ASA status III or IV.
• Moderate to severe obstructive or restrictive lung disease .
• Persistant intraoperative hemodynamic instability .
• Need for postoperative mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard	titated PEEP to best static compliance	standard PEEP of 5 cmH2O
titrate PEEP	titated PEEP to best static compliance	individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complication	postoperative 10 days after surgery	pneumonia-atelactasis-bronchospasm-respiratory failure

Secondary Outcome Measures

Name	Time	Method
Pulmonary functions test	postoperative 1st , 3rd and 5th day	This test includes these values :FVC (forced vital capacity ) FEV1( forced expiratory volume in one sec ) FEV1% and FVC%

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, القاهرة, Egypt