跳至主要内容
临床试验/NCT03114345
NCT03114345终止不适用

Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Measure of the hemoglobin quantity in the same area

研究概览

简要总结

Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

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

入选标准

  • •Educated consent signed,
  • •Older than 18,
  • •Paraplegia for at least 6 months,
  • •Surgery planned for pressure ulcer resection,

排除标准

  • •Dementia,
  • •Stade IV arteritis non-revascularisable,
  • •Patient with no health insurance,
  • •Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9),
  • •Patient taking part in another study which could impact the local micro-vascularization.

研究组 & 干预措施

Single arm

Other

Measurement of interface pressure and Measurement of micro-vascularization related parameters

干预措施: Measurement of interface pressure (Other)

Single arm

Other

Measurement of interface pressure and Measurement of micro-vascularization related parameters

干预措施: Measurement of micro-vascularization related parameters (Other)

结局指标

主要结局

Measure of the hemoglobin quantity in the same area

时间窗: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.

Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.

Measure of the pressure intensity in one area

时间窗: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.

Pressure intensity is recorded using a mapping pressure device (XSensor), set up on the patient hospital bed. Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.

次要结局

  • Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.(Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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