Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries

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

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate; Mechanical Ventilation Pressure High
• Intervention / Treatment: Other: titated PEEP to best static compliance

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wessam selima, MD; Phone Number: +201001958858; Email: w.z.selima@med.asu.edu.eg
• Study Contact Backup: Name: ghada sharafeldin, MSc; Phone Number: +201159296642; Email: ghadasharaf.92@gmail.com

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt
      • Recruiting
      • ain shams University
      • Contact: FATHY tash, prof; Email: REC-FMASU@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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
Experimental: titrate PEEP; individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O	Other: titated PEEP to best static compliance; the Intraoperative PEEP will be titrated to best static compliance for each patient
Active Comparator: standard; standard PEEP of 5 cmH2O	Other: titated PEEP to best static compliance; the Intraoperative PEEP will be titrated to best static compliance for each patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pulmonary complication	pneumonia-atelactasis-bronchospasm-respiratory failure	postoperative 10 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ventilation
• Other Study ID Numbers: FMASU MD259/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the results

Drug and device information, study documents

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