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

NCT ID: NCT06950112

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Obese Patients With Bariatric Surgery Lung Ultrasound Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

lung ultrasound

Intervention Type 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 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.

Group Type EXPERIMENTAL

lung ultrasound

Intervention Type 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 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.

Group Type EXPERIMENTAL

lung ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Gamal Ahmed Arakeeb

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Gamal Ahmed Arakeeb

Assistant lecturer of anesthesia faculity of medicine tanta university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tanta university

Tanta, El Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Gamal Arakeeb, Assistant Lecturer

Role: CONTACT

+201062411170

Facility Contacts

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Tanta University

Role: primary

+20403337544

Other Identifiers

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36265MD302/11/24

Identifier Type: -

Identifier Source: org_study_id

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