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临床试验/NCT05185141
NCT05185141招募中不适用

Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial

Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年1月11日最近更新:
适应症

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

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

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes M Wirkus, MD

Principal Investigator Johannes Wirkus, M.D.

Johannes Gutenberg University Mainz

研究点 (2)

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