Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in stroke volume following a fluid bolus.
研究概览
简要总结
The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.
详细描述
Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).
Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.
All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).
If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).
Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •written informed consent
- •scheduled major abdominal surgery
排除标准
- •Age <18 or >80 years
- •pregnancy
- •SIRS or sepsis
- •any kind of cardiac arrhythmia
- •known valve disease
- •known heart failure
- •any kind of known carotid stenosis
- •carotid doppler peak velocity >182 cm/s before baseline measurement (expected stenosis)
- •missing indication for invasive arterial blood pressure monitoring (IBP) not related to the study
- •peripheral artery disease (PAD)
- •BMI > 35 kg/m2
- •intraabdominal hypertension
- •ASA-PSC of 4
- •severe lung disease (e.g. COPD grade 3, fibrosis)
- •esophageal disease of any kind
- •participation in another clinical study
结局指标
主要结局
Change in stroke volume following a fluid bolus.
时间窗: Immediately before and 1 minute after completion of each fluid bolus.
A rise in stroke volume of ≥10% following a fluid bolus of 7ml/kg Ideal Body Weight is considered to reflect fluid responsiveness. Measurements will be assessed through esophageal doppler monitoring.
次要结局
未报告次要终点
研究者
Johannes M Wirkus, MD
Principal Investigator Johannes Wirkus, M.D.
Johannes Gutenberg University Mainz
