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NCT Number: NCT06950112

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

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

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Key information

Conditions

Obese Patients With Bariatric Surgery Lung Ultrasound Score

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta university

Tanta, El Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Tanta University

CONTACT

[email protected]

+20403337544

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The change in lung ultrasound score

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. Lung compliance

    Time frame: Periprocedural

    Lung compliance is a measure of the expansion of the lung.

  2. Hemodynamic parameter as oxygen saturation

    Time frame: Periprocedural

  3. Hemodynamic parameter as Heart rate

    Time frame: Periprocedural

  4. Hemodynamic parameter as Mean arterial blood pressure

    Time frame: Periprocedural

  5. End-tidal carbon dioxide (ETCO2)

    Time frame: Periprocedural

  6. Plateau Pressure (Pplat)

    Time frame: Periprocedural

  7. Peak airway pressure (Ppeak)

    Time frame: Periprocedural

  8. Incidence of early postoperative pulmonary complications

    Time frame: At the end of the surgery up to 24 hours after surgery

  9. Length of post anesthesia care unit "PACU" stay.

    Time frame: At the end of the surgery up to 2 hours after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Gamal Arakeeb, Assistant Lecturer

CONTACT

[email protected]

+201062411170

Sponsors and collaborators

Lead sponsor

Mahmoud Gamal Ahmed Arakeeb

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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