Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
研究概览
简要总结
The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O
详细描述
The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •general anesthesia,
- •hemodynamically stable
排除标准
- •intracranial hypertension,
- •pulmonary hypertension,
- •low blood pressure (MBP<80 mmHg),
- •Heart rate > 100 beats/min,
- •patient refusal
结局指标
主要结局
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
时间窗: Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment
次要结局
- Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)(Before recruitment and 20 minutes after recruitment)
- Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.(Before recruitment and at 20 minutes after recruitment)
- Pulmonary complications(up to 72 hours after surgery)
研究者
Diamanto Aretha
Anesthesiology Consultant Grade A, MD, Ph.D
General Hospital Of Pyrgos
