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Clinical Trials/NCT06950112
NCT06950112RecruitingNot Applicable

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

Mahmoud Gamal Ahmed Arakeeb1 site in 1 country60 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The change in lung ultrasound score

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: lung ultrasound (Device)

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.

Intervention: lung ultrasound (Device)

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.

Intervention: lung ultrasound (Device)

Outcomes

Primary Outcomes

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

  • End-tidal carbon dioxide (ETCO2)(Periprocedural)
  • Lung compliance(Periprocedural)
  • Hemodynamic parameter as oxygen saturation(Periprocedural)
  • Hemodynamic parameter as Heart rate(Periprocedural)
  • Hemodynamic parameter as Mean arterial blood pressure(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)

Investigators

Sponsor
Mahmoud Gamal Ahmed Arakeeb
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mahmoud Gamal Ahmed Arakeeb

Assistant lecturer of anesthesia faculity of medicine tanta university

Tanta University

Study Sites (1)

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