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临床试验/NCT03317288
NCT03317288已完成不适用

Effect of Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Sacral Skin Blood Flow During Supine Lying

研究概览

简要总结

The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP) overlay could be beneficial to preventing skin damage during daily activities, such as lying in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used to increase skin tolerance when lying in bed for an extended period of time (40 minutes), including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen and nutrients to skin) as compared to regular operation room (OR) overlay.

A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo study procedures including: AP and Control protocols. Skin blood flow and interface pressure will be collected non-invasively (from outside the body) during both protocols. During AP protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol, subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side (10 min). Subject will then proceed to vascular control measures, including: non-invasive skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation. Findings from this study will help us understand the effectiveness of the AP overlay on skin blood flow response during prolonged lying in bed.

详细描述

Tissue ischemia is one of the main etiologies of pressure injury. It is inevitable during bed-ridden and wheelchair bound conditions, such as spinal cord injury (SCI), or prolonged surgery procedure in the operating room. Active alternating pressure (AP) mattresses are covered by Medicare policy for patients with multiple/large stage 2/ stage 3 pressure injuries to relief interface pressure and prevent recurrence of pressure injuries. Previous studies demonstrated that the protective mechanisms of AP on pressure injury include redistribution of surface pressure, and allowing more blood supplies while lying on the support surface. The Dabir AP overlay is low profile yet possesses similar characteristics as other AP mattresses on the market; it is intended for clinical use, such as operation room (OR) where AP mattresses may not be an option. We expect Dabir AP overlay will be beneficial to people at risk of pressure injury by maintaining the blood supply during weight bearing condition.

The objective of this study is to evaluate the protective mechanisms of Dabir AP overlay on weight bearing tissue of people with chronic spinal cord injury (SCI). Our central hypothesis is that the Dabir AP overlay will cause lower amount of interface pressure and allow more skin blood flow during weight bearing as compared to regular OR overlay.

Each subject will undergo two study protocols: AP and control, and the order of the protocols will be randomized by drawing one envelope from the envelope pool. We will start with a pool of total 20 envelopes (10 envelopes indicating AP protocol first, and 10 envelopes indicating control protocol first). A 30-minute washout period will be provided in between the two protocols. Two Laser Doppler flowmetry (LDF) flat probes (moor instrument, Wilmington, DE) will be taped to the sacrum and one heel to collect the skin blood flow response throughout both AP and control protocols. A whole body pressure mapping system will be used between the subject and the overlay to collect the inter pressure data. For the AP cycle, we will use four 10-minute cycles (5 minutes of high pressure and 5 minutes of low pressure).

AP protocol: The subject will first lie on his/her side quietly for 10 minutes to collect the baseline skin blood flow, followed by lying supine on the Dabir AP overlay for 40 minutes, and then side lying for 30 minutes to collect the first reactive hyperemic response. To test the effect of preconditioning, the subject will then lie supine on the OR overlay for 40 minutes followed by side lying for 30 minutes for the second reactive hyperemic response.

Control protocol: The subject will first lie on his/her side quietly for 10 minutes to collect the baseline skin blood flow, followed by lying supine on the OR overlay for 40 minutes, and then side lying for 30 minutes to collect the reactive hyperemic response for control protocol.

研究设计

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

盲法说明

Here is no masking of the intervention.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have had spinal cord injury for more than one year
  • have injury level at T10 or above
  • not ambulatory and use a wheelchair for mobility
  • none smokers or able to refrain from smoking four hours prior to and during the study

排除标准

  • current pressure ulcer
  • history of diabetes mellitus
  • history of cardiovascular diseases
  • history of hypertension
  • history of pulmonary diseases
  • pregnant women (based on a positive pregnancy test)
  • Non-English speakers

结局指标

主要结局

Sacral Skin Blood Flow During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Sacral Averaged Interface Pressure During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the sacrum.

Heel Skin Blood Flow During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Heel Peak Interface Pressure During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the heel.

Sacral Peak Interface Pressure During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Sacral peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the sacrum.

Heel Averaged Interface Pressure During Supine Lying

时间窗: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Heel averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the heel.

次要结局

  • Post Alternating Pressure Heel Skin Blood Flow(40 minutes)
  • Post Alternating Pressure Sacral Peak Interface Pressure(40 minutes)
  • Post Alternating Pressure Sacral Skin Blood Flow(40 minutes)
  • Post Alternating Pressure Heel Averaged Interface Pressure(40 minutes)
  • Post Alternating Pressure Sacral Averaged Interface Pressure(40 minutes)
  • Post Alternating Pressure Heel Peak Interface Pressure(40 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Ting Tzen

Assistant professor

University of Illinois at Chicago

研究点 (2)

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