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临床试验/NCT04972500
NCT04972500已完成不适用

The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Changes in heart rate (HR)

研究概览

简要总结

Preoperative fasting is considered to be refraining from taking meals for at least 6 hours and clear fluids for at least 2 hours before anesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of chyme and the occurrence of Mendelson's syndrome, and on the other hand, it is one of the causes of water and carbohydrate disturbances in patients undergoing general anesthesia. Most of them experience some degree of dehydration in the preoperative period. It is associated with a worse prognosis. Due to the negative impact of fasting on homeostasis, as well as significant changes in heart rate in participants in the previous study, we decided to measure the hemodynamic parameters during fasting. The development of impedance cardiography techniques enables the measurement of these parameters by a non-invasive method.

After obtaining the participant's written consent to participate in the study, the first measurement of body weight, blood pressure using a non-invasive method and hemodynamic parameters using a non-invasive impedance cardiography method using the Niccomo ™ device (Medizinische Messtechnik GmbH) will be performed in the evening. The subject will then be asked to refrain from food for at least 10 hours and fluid for 6 hours before the next measurement. The next morning, another measurement will be made and the participant will be randomly assigned to one of two groups: subjects in the first group will be asked to refrain from eating and drinking for another 2 hours, while subjects in the second group per os will receive 400 milliliters of PreOp® (Nutricia ™ preparation intended for preoperative dietary management in surgical patients, containing carbohydrates and electrolytes). After another two hours, the third measurement of the tested parameters will be performed. The obtained results will be subjected to statistical analysis consisting in comparing the values of hemodynamic parameters between the studied groups at appropriate measurement points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •American Society of Anesthesiology (ASA) general condition assessment 1 or 2

排除标准

  • •Chronic kidney disease
  • •Circulatory failure
  • •Lung diseases
  • •Diseases of the heart valves
  • •History of hypoglycaemic episodes or any carbohydrate disturbance.
  • •Height less than 120 cm or greater than 230 cm
  • •Body weight less than 30 kg or greater than 155 kg.

研究组 & 干预措施

Pre-op

Experimental

Nutricia Pre-op, 400 milliliters, per os

干预措施: Nutricia Pre-op, 400 milliliters, per os (Dietary Supplement)

Control

No Intervention

No intervention

结局指标

主要结局

Changes in heart rate (HR)

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Heart rate will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Heart rate will be measured in 1/min (beats per minute).

Changes in cardiac index (CI)

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Cardiac index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Cardiac index will be measured in l/min/m\^2 (liters per minute per square meter).

Changes in systemic vascular resistance index (SVRI)

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Systemic vascular resistance index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Systemic vascular resistance index will be measured in dyn\*s\*cm\^-5\*m\^2 (dyne multiply by second multiply by centimeters to the power of minus 5 multiply by square meter)

Changes in stroke volume (SV)

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Stroke volume will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Stroke volume will be measured in mL (milliliters).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radosław Owczuk

Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

Medical University of Gdansk

研究点 (1)

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