A Comparison of Driving Pressure Guided Mechanical Ventilation With Lung Protective Ventilation Among Patients Presenting for Elective Surgeries at a Tertiary Care Hospital; A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Intra-operative pulmonary compliance
研究概览
简要总结
Patient undergoing surgeries in general anesthesia require support of their breathing by ventilator. Different strategies can be used to manage breathing of the patient. Lung protective ventilation provides breathing at a set volume determined by patient ideal body weight, along with a set rate to maintain adequate breathing. The pressures in the lower airway are kept less than 30 cm of H20 while a pressure of 5cm of H20 is applied to prevent lung collapse. Recently to above mentioned regimen a driving pressure is added which is a difference between lower airway pressure and pressure applied to prevent lung collapse. Ventilatory settings are adjusted to keep this driving pressure less than 15 cm of H2O.
详细描述
Lung protective ventilation provides tidal volume at 6-8 ml/kg along with a set respiratory while keeping plateau pressure less than 30cm of H2O and Peak pressure less than 35cm of H2O and PEEP of 5cm of H20 is applied. The aim is to prevent volutrauma, barotrauma and atelectrauma. To above mentioned regimen another parameter is added that is driving pressure. It is manipulated by adjusting PEEP level so that difference between Plateau Pressure and PEEP is less than equal to 15cm of water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) class: I and II.
- •Elective laparoscopic surgeries requiring General Anesthesia and Mechanical ventilation
- •Patients receiving neuromuscular blockade during surgery.
- •Receiving Mechanical ventilation for at least 1h.
排除标准
- •Pregnancy
- •Patients who had received mechanical ventilation of more than 1h in the previous 2 weeks.
- •Body mass index >35 kg/m2
- •Smokers and ASA class III and above.
- •Thoracic and Cardiac surgery
研究组 & 干预措施
Lung Protective ventilation
干预措施: Lung protective ventilation (Device)
Driving pressure guided ventilation
干预措施: Driving pressure guided ventilation (Device)
结局指标
主要结局
Intra-operative pulmonary compliance
时间窗: This will be measured at 10 minutes interval in the intraoperative period and then mean will be calculated.
次要结局
- Intra-operative blood pressure(This will be Systolic, Diastolic and Mean Blood pressure measured at baseline and then 10 minutes interval in the intraoperative period. Mean will be calculated for comparison across groupss.)
- Oxygenation index(This will be the ratio of PaO2/FiO2 and this will be measured during surgery (at time of skin closure))
- PEtCO2-PaCO2 gradient(This will be the PEtCO2-PaCO2 gradient and this will be measured during surgery (at time of skin closure))
- Post operative pulmonary complications(This will be the need for prolonged ventilatory support, need for re-intubation ,need for supplemental oxygenation and its duration, PaO2/FiO2 ratio less than 300, pneumothroax. These will be observed in first 24hours after surgery.)
研究者
Huda Tariq
Principal Investigator
Rawalpindi Medical College