血压测量、血压的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

撤销

条件

详细说明

The measurement of blood pressure is an important physiological parameter in cardiovascular health. The accurate and continuous monitoring of blood pressure assures optimal care in various clinical settings. Blood pressure can be measured both by invasive and non-invasive methods. Measurement of blood pressure via arterial cannulation is the direct invasive clinical reference method. However, because invasive blood pressure measurement requires trained clinicians and involves potential complications, non-invasive blood pressure measurement is preferred. Non-invasive method uses non-invasive sphygmomanometers.

Non-invasive blood pressure measurement is based on the estimation of blood pressure. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. Safety and performance of automated sphygmomanometers are complied with IEC 80601-2-30:2018 and ISO 81060-2:2018: AMD2 (approved).

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

芬兰
- - Helsinki、芬兰、00290
    - Helsinki University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Patient treated in Meilahti Hospital Cath Lab

描述

Inclusion Criteria:

Age requirement: 18 and over.
Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
Able to provide written informed consent.
Expected to remain in the unit for the duration of the study procedure.

Exclusion Criteria:

Have previously participated in this study (no subject may participate more than once).
Pregnant and lactating women per site standard of care.
Subjects with peripheral arterial diseases (causing left/right arm difference).
Subjects with complications, who is on vasoactive agents at discretion of the PI.
Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
Are suffering from infection(s) or immunocompromised patients that require isolation.
PI or designee decision due to subject health conditions

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures 大体时间：From admission to discharge	The primary outcome will be the collection of blood non-invasive blood pressure measurements and invasive blood pressure measurements from adult, using NIBP Standard Parameter enhancement per ISO 81060-2 requirements. Per subject, Non-Invasive Blood Pressure and Invasive Blood Pressure endpoints are collected for: Systolic BP (mmHg) Diastolic BP (mmHg) NIBP and IBP Mean Arterial Blood Pressure (MAP)	From admission to discharge

其他结果措施

结果测量	措施说明	大体时间
Collection of safety information 大体时间：From admission to discharge	The safety outcome of this study is to collect safety information, including type and number of AEs, SAEs, and any device issues	From admission to discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GE Healthcare

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月14日

初级完成 (估计的)

2025年9月30日

研究完成 (估计的)

2025年12月31日

研究注册日期

首次提交

2025年3月31日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新