Assessment of End-Tidal Carbon Dioxide Changes in Response to Passive Leg Raise for Guiding Fluid Management in Lung Resections: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in End-Tidal Carbon Dioxide (EtCO₂) in Response to Passive Leg Raise (PLR)
研究概览
简要总结
Aim: End tidal carbondioxide pressure (EtCO2) is an indirect indicator of cardiac output (CO) which is monitored in every patient at perioperative setting. The investigators aimed to use increase of EtCO2 as a response to passive leg raising maneuver (PLR) to indicate fluid responsiveness in patients who underwent lung resection with video-assisted thoracoscopic surgery (VATS).
详细描述
Materials and Methods
50 patients included who are eligible according to inclusion criteria of the study who underwent lung resection operation via VATS between Agust 2020-March 2021. After a standardized anesthesia induction protocol and intubation, PLR is applied to all patients as soon as anesthesia depth and ventilation stabilized. An increase of 2 mmHg at EtCO2 at first minute of PLR evaluated as "fluid responsive" due to an increase of venous return. Responsive patients divided into two groups as "study" and "control" when unresponsive patiens inclueded into "unresponsive" group. Patients at study group received a fluid bolus (250 ml (and an additional 250 ml if mean arterial pressure remained below 65 mmHg )) in addition to maintainence fluid as control group and unresponsive group received only maintainence fluid. Hemodynamic data, surgery duration, total iv fluid administration, use of blood products, bleeding and urine output during surgery of all patients recorded. Preopretive and postoperative urea, creatinine and lactate levels of all patiens compared. Total iv fluid administration and urine output recorded during postoperative 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lung resection surgery via VATS
- •ASA I-II-III
- •Patients older than 18 years
排除标准
- •ASA IV or more
- •Post operative ICU stay
- •Resections greater than lobectomy
- •History of renal and heart failure
- •Patients younger than 18 years.
研究组 & 干预措施
Control
PLR applied to this group as well as other two groups. An increase of 2mmHg detected in these patients. However, this group received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion. The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients.
Study
PLR applied to this group as well as other two groups. A 2 mmHg increase at EtCO2 detected at 1st minute of PLR. The patients in this group named as study group and received a 250 ml of crystalloid bolus. These patients also received another 250 ml crystalloid bolus if mean arterial pressure is below 65 mmHg at the end of infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg after total of 500 ml crystalloid bolus.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients.
干预措施: 250 ml crystalloid bolus infusion (Other)
Unresponsive
Patients in this group showed no change at End tidal carbon dioxide measurement as a response to PLR and received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients.
结局指标
主要结局
Change in End-Tidal Carbon Dioxide (EtCO₂) in Response to Passive Leg Raise (PLR)
时间窗: Time Frame: Intraoperative (Baseline and 1 Minute After PLR)
Measurement Method: EtCO₂ (mmHg) will be recorded using a side-stream capnograph integrated into the anesthesia workstation. Baseline EtCO₂ will be measured in the supine position before the PLR maneuver. The PLR maneuver will then be performed by elevating the lower extremities to a 45-degree angle while maintaining a supine upper body position. The position remained for 1 minute and the maximum level of EtCO₂recorded. Outcome Definition: A ≥2 mmHg increase in EtCO₂ from baseline within 1 minute of PLR will be classified as a positive response, indicating fluid responsiveness. Patients with an EtCO₂ increase of \<2 mmHg will be classified as non-responders.
次要结局
- Change in Serum Urea Levels(Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized))
- Change in Serum Creatinine Levels(Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized))
- Change in Serum Lactate Levels(Preoperative, 24 hours)
研究者
Havva Suheyla Akin Uzan
doctor
Istanbul University - Cerrahpasa