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临床试验/NCT04934761
NCT04934761已完成不适用

Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work

Guangzhou Red Cross Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月1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
发起方
入组人数
20
试验地点
1
主要终点
Ea

研究概览

简要总结

By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

详细描述

Objective

By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •ASAI-II age 40- 70 weight 48 - 72 kg.

排除标准

  • •Body mass index >30 or <15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments

研究组 & 干预措施

capacity shock

Experimental

2ml/kg succinylateol gelatin

干预措施: Fluid challenge strategy (Procedure)

routine management

Other

conventional strategy

干预措施: conventional strategy (Procedure)

结局指标

主要结局

Ea

时间窗: At the end of surgery

Ea(Arterial elasticity, mmHg·ml)

SW

时间窗: At the end of surgery

SW(Stroke Volume,mmHg·ml)

Ees

时间窗: At the end of surgery

Ees(End-systole Elasticity,mmHg/ml)

Ea

时间窗: Baseline,after induction

Ea(Arterial elasticity, mmHg·ml)

Ees

时间窗: Baseline,After induction

Ees(End-systole Elasticity,mmHg/ml)

Ees

时间窗: Immediately after the intervention,complete of the first round of the fluid challenge

Ees(End-systole Elasticity,mmHg/ml)

Ees

时间窗: Immediately after the intervention,complete of the second round of the fluid challenge

Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance

Ees

时间窗: 1h after the first fluid challenge

Ees(End-systole Elasticity,mmHg/ml)

SW

时间窗: Baseline,after induction

SW(Stroke Volume,mmHg·ml)

SW

时间窗: Immediately after the intervention,complete of the first round of the fluid challenge

SW(Stroke Volume,mmHg·ml)

SW

时间窗: Immediately after the intervention,complete of the second round of the fluid challenge

SW(Stroke Volume,mmHg·ml)

SW

时间窗: 1h after the first fluid challenge

SW(Stroke Volume,mmHg·ml)

Ea

时间窗: Immediately after the intervention,complete of the first round of the fluid challenge

Ea(Arterial elasticity, mmHg·ml)

Ea

时间窗: Immediately after the intervention,complete of the second round of the fluid challenge

Ea(Arterial elasticity, mmHg·ml)

Ea

时间窗: 1h after the first fluid challenge

Ea(Arterial elasticity, mmHg·ml)

次要结局

未报告次要终点

研究者

发起方
Guangzhou Red Cross Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liang Bing

Deputy Director of Anesthesiology Physicians

Guangzhou Red Cross Hospital

研究点 (1)

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