Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Average norepinephrine infusion rate
研究概览
简要总结
The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
排除标准
- •Patients with the following exclusion criteria:
- •high risk surgery according to the 2022 ESC guideline "Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery"
- •Surgery in which pneumatic calve compression is indicated according to ERAS guidelines
- •Surgery which interferes with the installation or correct function of PLC
- •Sepsis (according to current Sepsis-3 definition)
- •Pregnancy
- •Congestive heart failure NYHA III/IV
- •American Society of Anesthesiologists (ASA) physical status classification V or VI
- •Interference of PLC and patient positioning (e.g.; extreme Trendelenburg positioning, lithotomy positioning)
- •Contraindications for the use of PLC according to the German guideline13 (e.g., extensive thrombophlebitis, thrombosis or suspected thrombosis of the lower limbs, erysipelas, acute phlegmon, limb compartment syndrome, severe uncontrolled arterial hypertension, lymphatic drainage disorder proximal to PLC, extensive open soft tissue trauma, autoimmune blistering skin conditions such as IgA bullous dermatosis or bullous pemphigoid)
研究组 & 干预措施
Pneumatic leg compression
PLC group (i.e., intervention group):
Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery.
干预措施: Pneumatic leg compression (Device)
Routine care
Routine care group (i.e., control group):
Patients assigned to the Routine care group will not receive a pneumatic lower limb compression sleeve. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist.
结局指标
主要结局
Average norepinephrine infusion rate
时间窗: Intraoperative
Average intraoperative norepinephrine infusion rate \[μg kg-1 min-1\] needed to keep MAP above 65mmHg. The average intraoperative norepinephrine infusion rate will be calculated using the absolute amount of norepinephrine administered per kg bodyweight \[μg kg-1\] divided by the duration of surgery (between surgical incision and suture) \[min\] (continuous outcome)
次要结局
- Lowest intraoperative MAP [mmHg](Intraoperative)
- Cumulative intraoperative time with MAP <65 mmHg [min](Intraoperative)
- Intraoperative area under a MAP of 65 mmHg(Intraoperative)
- Intraoperative time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time)(Intraoperative)
- Volume of crystalloid fluid given during surgery [ml](Intraoperative)