CTRI/2022/10/046764已完成不适用
A comparative study of driving pressure guidedindividualized versus fixed positive end expiratory pressureon incidence of postoperative lung atelectasis in patientsundergoing laparoscopic surgeries in trendelenburg position: A double blinded random
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To identify whether an individualized PEEP guided by driving pressures can reduce the magnitude of postoperative ( 30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung ultrasound score
研究概览
简要总结
- The study will be done on patients undergoing laparoscopic urological or gynecological surgeries in trendelenberg position.
- 82 randomized patients will be recruited of which 41 patients will be assigned to study group and 41 patients will be assigned to control group.
- The participants in the test group shall receive driving pressure guided individualized PEEP and the control group participants shall receive fixed PEEP throughout the surgery.
- Driving pressures would be calculated by using the formula (Pplat - PEEP) and the PEEP at which lowest possible driving pressures are observed is fixed throughout the surgery.
- Lung recruitment will be done in both the study groups. Incremental PEEP protocol shall be used in test group.
- The principal investigator is blinded to the study groups and the intervention will be done by an experienced anesthesiologist in the operation theater.
- After the patient is shifted to the post anesthetic care unit lung ultrasound will be done by the principal investigator to look for any B lines and lung consolidation and Lung Ultrasound Sore (LUS) will be determined based on USG findings.
- Other parameters like intra operative arterial blood gas analysis, ventilatory parameters, vitals, details of the surgery will be recorded in the case record form.
- On completion both the groups will be studied and analyzed independently and various parameters mentioned above will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing laparoscopic urological and gynaecological surgeries.
- •ASA PS 1 & 2 patients.
排除标准
- •Patients refusal to participate in the study 2) Previous thoracic surgeries or massive blood loss >40ml/Kg 3) Patients with ARDS / lung injury / COPD / chronic lung disease.
- •Recent history of upper respiratory tract infection/ history of bronchial asthma 5) Significant cardiac, renal or hepatic disease.
- •BMI <18 or >30 Kg/m2.
结局指标
主要结局
To identify whether an individualized PEEP guided by driving pressures can reduce the magnitude of postoperative ( 30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung ultrasound score
时间窗: 24 hours after extubation of the patient
次要结局
- Post operative oxygen requirement(Post operative period)
研究者
研究点 (1)
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