Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery

Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery: a Prospective Randomized Controlled Trial

this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score

Study Overview

• Status: Recruiting
• Conditions: Lung Ultrasound Score; Obese Patients With Bariatric Surgery
• Intervention / Treatment: Device: lung ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Gamal Arakeeb, Assistant Lecturer; Phone Number: +201062411170; Email: Mahmoud.arakeep@med.tanta.edu.eg

Study Locations

• Egypt
  • El gharbia
    • Tanta, El gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Tanta University; Phone Number: +20403337544; Email: dean@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. patients who have a BMI 30-40 kg/m2
2. American Society of Anesthesiologists (ASA) physical status II or III
3. patients aged between 18 and 60 years,
4. patients scheduled to undergo laparoscopic bariatric surgeries.

Exclusion Criteria:

1. patients' refusal to participate in the study,
2. previous history of thoracic surgery,
3. Patients with a history of chest disease (COPD, emphysema, or pneumothorax),
4. Patients with abnormal pre-operative chest radiographs, such as pneumonia and pleural effusion,
5. Patients with right-side heart failure or impending failure,
6. Patients with known hypovolemia, and Patients with increased intracranial pressure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D (Driving pressure); Patients will be ventilated with driving pressure-guided ventilation with VT 6-8 ml /kg of predicted body weight, and after recruitment, we will return to the baseline PEEP 5 cmH2O that will be increased by 2 cmH2O until reaching the lowest possible driving pressure for every patient. Each PEEP level will be maintained for ten respiratory cycles and DP will be calculated at the last cycle.	Device: lung ultrasound; The lung ultrasound score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation). The aeration score will be built by the sum of the scores of the 12 segments, with a minimum of 0 and a maximum of 36 according to the aeration loss.
Experimental: Group L (Lung protective strategy); Patients will be ventilated with protective lung strategy with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to PEEP of 8-10 cm H2O that will be maintained until the end of surgery.	Device: lung ultrasound; The lung ultrasound score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation). The aeration score will be built by the sum of the scores of the 12 segments, with a minimum of 0 and a maximum of 36 according to the aeration loss.
Experimental: Group P (Physiological PEEP); Patients will be ventilated with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to physiological PEEP of 5 cm H2O that will be maintained until the end of surgery.	Device: lung ultrasound; The lung ultrasound score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation). The aeration score will be built by the sum of the scores of the 12 segments, with a minimum of 0 and a maximum of 36 according to the aeration loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in lung ultrasound score	The primary outcome will be the change in Lung Ultra Sound Score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation) from the base line.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung compliance	Lung compliance is a measure of the expansion of the lung.	Periprocedural
Hemodynamic parameter as oxygen saturation		Periprocedural
Hemodynamic parameter as Heart rate		Periprocedural
Hemodynamic parameter as Mean arterial blood pressure		Periprocedural
End-tidal carbon dioxide (ETCO2)		Periprocedural
Plateau Pressure (Pplat)		Periprocedural
Peak airway pressure (Ppeak)		Periprocedural
Incidence of early postoperative pulmonary complications		At the end of the surgery up to 24 hours after surgery
Length of post anesthesia care unit "PACU" stay.		At the end of the surgery up to 2 hours after surgery

Collaborators and Investigators

• Sponsor: Mahmoud Gamal Ahmed Arakeeb

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 36265MD302/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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