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临床试验/NCT03454802
NCT03454802已完成不适用

Passive Leg Raising - an Important Diagnostic Manoeuvre and Its Dependency on the Activity of the Autonomous Nervous System in Critically Ill Patients and Healthy Subjects

Region MidtJylland Denmark2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年9月1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
11
试验地点
2
主要终点
Changes in HRV frequency domain variables V

研究概览

简要总结

The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre.

The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU.

Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.

详细描述

See above

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Single (Participant)

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

  • Consenting after written and oral information

排除标准

  • Contraindications to PLR: intracranial or abdominal hypertension

结局指标

主要结局

Changes in HRV frequency domain variables V

时间窗: 10 minutes

Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)

Changes in HRV frequency domain variables VIII

时间窗: 10 minutes

HRV normalized power (%, normalized units, n.u.)

Changes in cardiovascular variables I

时间窗: 10 minutes

stroke volume, SV (mL)

Changes in cardiovascular variables III

时间窗: 10 minutes

blood pressure, BP (mmHg)

Changes in cardiovascular variables II

时间窗: 10 minutes

pulse rate, PR (min\^-1)

Changes in HRV frequency domain variables VII

时间窗: 10 minutes

HRV relative power (absolute power/total power)

Changes in HRV frequency domain variables IX

时间窗: 10 minutes

HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.

Changes in cardiovascular variables IV

时间窗: 10 minutes

pulse oximetric saturation, SpO2 (%)

Changes in HRV frequency domain variables VI

时间窗: 10 minutes

HRV absolute power (ms\^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)

次要结局

未报告次要终点

研究者

发起方
Region MidtJylland Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soren Sondergaard

Senior Consultant, MD, PhD

Region MidtJylland Denmark

研究点 (2)

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