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

2021년 5월 12일 업데이트: Yi-Ting Tzen, University of Illinois at Chicago

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

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

The PI, or key personnel will then collect the vascular control measures, including the heat hyperemic (HH) blood flow response, and the skin vasomotor response. A non-invasive combined laser Doppler and white light reflectance spectroscopy (LDF-WLRS) probe (CP2T-1000, Moor Instrument, Wilmington, DE) will be used for both measures.

HH blood flow response will be measured at the sacrum and one heel while the subject is in side-lying position. HH will be induced with the heater at the tip of the probe head (41°C for 5 minutes). This HH measure will take approximately 7 minutes (2 min-baseline, 5 min-heating) per location. In total, the HH measures will take up to 15 minutes to complete.

The skin vasomotor response will be induced using cutaneous electrical stimulation (3-10 mA, 0.2-1.0 ms pulses at 20 Hz, 1 s trains) delivered via 1 cm Ag-AgCl surface electrodes applied bilaterally (4 cm apart) to the forehead (above lesion) and the abdominal wall (below lesion) while the subject is in a semi-reclined position.12 For each site, 5-8 stimuli will be delivered randomly. CP2T-1000 probe will be used to collect SBF and tissue oxygenation data at pulp of the second finger and toe. Subject will be in a semi-reclined position (about 30° from horizontal plane) during this protocol, and it will take up to 15 minutes to complete this protocol.

Pressure mapping of wheelchair: (approximately 10 minutes) The subject will be asked to transfer back to his/her wheelchair with the pressure mapping system placed between the wheelchair and the subject to collect the interface pressure data. The pressure mapping system is the same as that used between the subject and overlay to collect the interface pressure data.

연구 유형

중재적

등록 (실제)

15

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Illinois
      • Chicago, Illinois, 미국, 60612
        • University of Illinois at Chicago

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: SCI subjects
The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.
The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sacral Skin Blood Flow During Supine Lying
기간: 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
40 minutes, the inflation-deflation cycle alternates every 10 minutes
Heel Skin Blood Flow During Supine Lying
기간: 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
40 minutes, the inflation-deflation cycle alternates every 10 minutes
Sacral Peak Interface Pressure During Supine Lying
기간: 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.
40 minutes, the inflation-deflation cycle alternates every 10 minutes
Sacral Averaged Interface Pressure During Supine Lying
기간: 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.
40 minutes, the inflation-deflation cycle alternates every 10 minutes
Heel Peak Interface Pressure During Supine Lying
기간: 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.
40 minutes, the inflation-deflation cycle alternates every 10 minutes
Heel Averaged Interface Pressure During Supine Lying
기간: 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.
40 minutes, the inflation-deflation cycle alternates every 10 minutes

2차 결과 측정

결과 측정
측정값 설명
기간
Post Alternating Pressure Sacral Skin Blood Flow
기간: 40 minutes
Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes
Post Alternating Pressure Sacral Peak Interface Pressure
기간: 40 minutes
Sacral peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes
Post Alternating Pressure Sacral Averaged Interface Pressure
기간: 40 minutes
Sacral averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes
Post Alternating Pressure Heel Skin Blood Flow
기간: 40 minutes
Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes
Post Alternating Pressure Heel Peak Interface Pressure
기간: 40 minutes
Heel peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes
Post Alternating Pressure Heel Averaged Interface Pressure
기간: 40 minutes
Heel averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.
40 minutes

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Yi-Ting Tzen, PhD, Assistant Professor

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 5월 12일

기본 완료 (실제)

2019년 3월 31일

연구 완료 (실제)

2019년 3월 31일

연구 등록 날짜

최초 제출

2017년 10월 10일

QC 기준을 충족하는 최초 제출

2017년 10월 17일

처음 게시됨 (실제)

2017년 10월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 12일

마지막으로 확인됨

2021년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2017-0215

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

It is not yet known if there will be a plan to make IPD available.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .