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临床试验/NCT05227729
NCT05227729已完成不适用

Descending Aorta Blood Flow to Guide Fluid Therapy During Surgery

Sykehuset Telemark1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in blood flow velocity in descending aorta

研究概览

简要总结

The investigators will perform a clinical observational study of patients undergoing abdominal surgery. The study will be performed at Sykehuset Telemark, Skien. The aims of the study are to compare suprasternal and transoesophageal Doppler (reference method) to measure blood flow in the proximal descending aorta and to explore the variability of hemodynamic variables during surgery.

详细描述

Background and aim: The best validated method to estimate cardiac output with ultrasound requires measuring the Doppler velocity time integral (VTI) in the left ventricular outflow tract measured from the apical (lateral chest) window/ projection. However, this projection is often out of reach for anaesthesiologists during many surgical procedures (e.g. abdominal surgery) due to draping, and is often difficult to perform if the patient cannot be placed in the left lateral decubitus position. Alternatively, VTI in the proximal descending aorta may be measured via the suprasternal view, which is one of the standard projections in transthoracic echocardiography. This view is often available for anaesthesiologists during surgery on a patient in supine position. Assuming that changes in cardiac output are associated with changes in VTI in proximal descending aorta, this may provide the anaesthesiologist with a non-invasive measure of the response to a fluid challenge. The first aim of this study is to evaluate the ability of suprasternal Doppler to measure blood flow in the proximal descending aorta, and its agreement with the reference method oesophageal Doppler, during ongoing abdominal surgery.

Fluid challenges are typically given when stroke volume is reduced by 10-15%, which is considered a significant reduction. This is however dependent on the precision of the measurements, which is estimated during hemodynamic stability. During surgery, on the other hand, the variability may be larger, leading to erroneously concluding that stroke volume is reduced due to volume loss, when in fact this may be due to other stimuli related to surgery (mechanical, e.g. compression of large veins or the thoracic cavity, or stimuli affecting the autonomic nervous system, e.g. pain). The proportion of potentially falsely measured reduction may be calculated by performing repeated measurements during ongoing surgery. Thus, an other aim with this study is to explore the variability of measurements of stroke volume during surgery.

Study design: Clinical observational study.

Data collection: 30 patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 hrs estimated duration. The patients should be of American Society of Anesthesiologists physical status 1-3 and have no contraindications to the use of oesophageal ultrasound. Hemodynamic data will be downloaded to a PC continuously from the clinical monitoring equipment (Philips Intellivue) using the VSCapture software (https://github.com/xeonfusion/VSCaptureMP) in VisualStudio (Microsoft). "Landmarks" in the procedure (e.g. surgical incision, manipulation in the surgical field and hemorrhage) will be recorded manually to relate the hemodynamic data to the different steps in the procedure. Blood flow velocity in the descending aorta will be measured using ultrasound machines in ordinary clinical use (GE Venue R 2.5; GE Healthcare). The Doppler recordings will be analyzed using commercially available software (EchoPAC; General Electric) after blinding.

Data analyzes:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to undergo laparoscopic or open abdominal surgical procedures (gastrointestinal or gynecological) of at least 1.5 h estimated duration.
  • The patients should be of American Society of Anesthesiologists physical status 1-3

排除标准

  • Pathology in the larynx, oesophagus or stomach
  • Former surgery in larynx, oesophagus or stomach
  • Thoracic aortic aneurysm.

结局指标

主要结局

Change in blood flow velocity in descending aorta

时间窗: During surgery, every 5 minutes. At least over a time period of 1,5 hours

Transoesophageal Doppler

Change in stroke volume

时间窗: During surgery, every 5 minutes. At least over a time period of 1,5 hours

Calculated from the measurements by transoesophageal Doppler

次要结局

  • Change in heart rate(During surgery, every 5 minutes. At least over a time period of 1,5 hours)
  • Change in systemic vascular resistance(During surgery, every 5 minutes. At least over a time period of 1,5 hours)
  • Change in blood pressure(During surgery, every 5 minutes. At least over a time period of 1,5 hours)

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Torkjell Nostdahl

Principal investigator

Sykehuset Telemark

研究点 (1)

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