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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in lung ultrasound score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: lung ultrasound (Device)
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.
干预措施: lung ultrasound (Device)
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.
干预措施: lung ultrasound (Device)
结局指标
主要结局
The change in lung ultrasound score
时间窗: 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.
次要结局
- 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)
研究者
Mahmoud Gamal Ahmed Arakeeb
Assistant lecturer of anesthesia faculity of medicine tanta university
Tanta University