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临床试验/NCT04396288
NCT04396288已完成不适用

Characterization of Intra-osseous Vascular Response With Ultrasound Imaging on Healthy Volunteers

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年9月14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
19
试验地点
1
主要终点
Change of velocity of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)

研究概览

简要总结

Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be 18 years old or older
  • speaks good French
  • have an affiliation to a French Healthcare system (health insurance)
  • sign the informed consent

排除标准

  • bone fracture at the tibia or at the forearm less than one year ago
  • injury or wound still present at the tibia or at the forearm
  • pregnant women
  • protected persons

研究组 & 干预措施

Healthy volunteers

Experimental

干预措施: ultrasound imaging at the forearm and at the tibia (Device)

结局指标

主要结局

Change of velocity of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)

时间窗: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff

Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.

Change of direction of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)

时间窗: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff

Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.

Change of velocity of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position

时间窗: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)

Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.

Change of direction of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position

时间窗: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)

Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.

次要结局

  • Repeatability of the measurement of the change of intraosseous blood circulation at the tibia when changing position from sitting position to supine head-down tilt position(During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes))
  • Repeatability of the measurement of the change of intraosseous blood circulation at the forearm under the action of an automatic blood pressure cuff(Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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