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临床试验/NCT05554315
NCT05554315已完成不适用

Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月19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
40
试验地点
1
主要终点
Use of sPTT as a marker for blood pressure.

研究概览

简要总结

Background:

Blood pressure is one of the key markers of cardiovascular health. High blood pressure, also called hypertension, can increase the risk of heart disease or stroke. Monitoring a person s blood pressure continuously over a 24-hour period at home is the best way to diagnose hypertension, but the equipment currently used to do it is cumbersome. This natural history study will test a new technique for monitoring blood pressure continuously over time.

Objective:

To test a new technique (speckle plethysmography) for measuring blood pressure in healthy adults.

Eligibility:

Healthy people aged 18 years and older.

Design:

Participants will come to the clinic a minimum of 2 times.

The screening visit will last up to 2 hours. Participants will have a physical exam. Their vital signs will be taken.

The clinical visit will last up to 1 hour. Participants will recline in a chair. Sensors to measure the activity of the heart will be placed on their chest. Different sensors will be placed on two fingers and one big toe. A device to measure blood pressure will be placed on one arm.

While wearing the sensors, participants will undergo 3 tests:

They will be asked to breathe slowly for 2 minutes.

They will be asked to solve a math problem.

They will immerse one hand or foot into an ice bath for up to 2 minutes.

Each test will be followed by a 5-minute recovery period.

Participants may elect to return for up to 3 more visits during the following week.

详细描述

Study Description:

This pilot study will investigate the use of a recently introduced optical technique, speckle plethysmography (SPG), as an alternative to photoplethysmography (PPG) for cuff-free blood pressure (BP) estimation using pulse transit time (PTT). Because of the increased signal quality of SPG in comparison to PPG, we hypothesize that pulse transit times calculated from ECG-SPG (sPTT) will have a better correlation to blood pressure than ECG-PPG (pPTT).

Objectives:

Primary Objective:

To examine the use of sPTT as a marker for blood pressure.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Male or female, aged 18 or greater.
  • In good general health as evidenced by medical history and physical.

排除标准

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Any active cardiovascular or pulmonary disorders or use of vasoactive medications.
  • History of aneurysm or stroke.
  • Pregnant by history.
  • History of fainting or seizures.
  • An open cut, sore, or bone fracture on or near the hands or feet.
  • Known retinopathy, intraocular lens implantation, or glaucoma.
  • Any other condition that in the opinion of the investigator would place the participant at unacceptable risk.

研究组 & 干预措施

1

Male or female, aged 18 or greater in good general health as evidenced by medical history

结局指标

主要结局

Use of sPTT as a marker for blood pressure.

时间窗: 1 year

To examine the use of sPTT as a marker for blood pressure.

次要结局

  • use of sPTT in comparison to pPTT(1 year)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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