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

NCT06950112 | Recruiting DMC

• 1 other identifier: 36265MD302/11/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese Patients With Bariatric Surgery; Lung Ultrasound Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Lung compliance

  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

Study Arms (3)

Group D (Driving pressure)

EXPERIMENTAL

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

Group L (Lung protective strategy)

EXPERIMENTAL

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

Group P (Physiological PEEP)

EXPERIMENTAL

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

Interventions

lung ultrasound DEVICE

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.

Group D (Driving pressure); Group L (Lung protective strategy); Group P (Physiological PEEP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahmoud Gamal Ahmed Arakeeb: lead

Study Sites (1)

Tanta university

Tanta, El Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mahmoud Gamal Arakeeb, Assistant Lecturer

CONTACT

+201062411170; Mahmoud.arakeep@med.tanta.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: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia faculity of medicine tanta university

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 29, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)