Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- post-operative pulmonary complications
研究概览
简要总结
the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery
详细描述
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Group OLA: The patients will undergo ARM followed by personalized PEEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant, Care Provider
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 - 65 years
- •BMI between 30-40 kg/m²
- •ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery
排除标准
- •Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 < 80% of the predicted value)
- •active asthma, acute respiratory distress syndrome
- •history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
- •significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
结局指标
主要结局
post-operative pulmonary complications
时间窗: one week postoperative
Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
次要结局
- heart rate(Baseline (before surgery) and intraoperative)
- length of hospital stay,(postoperative up to one month)
- pulmonary complications.(one week postoperative)
- mean arterial blood pressure(Baseline (before surgery) and intraoperative)
- airway pressure(intraoperative)
- tidal volume(intraoperative)
- SpO2(Baseline (before surgery) and intraoperative)
- ETCO2(Baseline (before surgery) and intraoperative)
研究者
Marwa Mohamed Medhat
lecture of anesthesia and surgical intensive care (Principal Investigator)
Zagazig University