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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06950112
Enrollment
60
Registered
2025-04-29
Start date
2024-12-01
Completion date
2026-11-01
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Ultrasound Score, Obese Patients With Bariatric Surgery

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

Interventions

DEVICElung 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.

Sponsors

Mahmoud Gamal Ahmed Arakeeb
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The change in lung ultrasound scorePeriproceduralThe 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.

Secondary

MeasureTime frameDescription
Hemodynamic parameter as oxygen saturationPeriprocedural
Hemodynamic parameter as Heart ratePeriprocedural
Hemodynamic parameter as Mean arterial blood pressurePeriprocedural
End-tidal carbon dioxide (ETCO2)Periprocedural
Lung compliancePeriproceduralLung compliance is a measure of the expansion of the lung.
Peak airway pressure (Ppeak)Periprocedural
Incidence of early postoperative pulmonary complicationsAt 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
Plateau Pressure (Pplat)Periprocedural

Countries

Egypt

Contacts

Primary ContactMahmoud Gamal Arakeeb, Assistant Lecturer
Mahmoud.arakeep@med.tanta.edu.eg+201062411170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026