Pressure Ulcer Development Device Related (Pneumatic)
From Prevention to Complication: A Silent Risk of Intermittent Pneumatic Compression in Postoperative and Critical Care
연구 개요
상태
상세 설명
This retrospective cohort study aims to evaluate the occurrence of pressure ulcers associated with IPC device use and to identify patient- and treatment-related factors associated with their development. The study will include adult patients hospitalized in surgical wards and/or intensive care units who received IPC therapy during the study period. Data will be extracted from electronic health records, including demographic characteristics, comorbidities (e.g., diabetes mellitus, peripheral vascular disease), clinical status (including hemodynamic support and mobility), and detailed information regarding IPC utilization, such as duration of use and documentation of device application and skin assessments.
The primary outcome is the development of device-related pressure ulcers, defined according to the NPUAP staging system and localized to anatomical areas in contact with IPC sleeves. Secondary analyses will assess the association between duration of IPC exposure, patient risk factors, and ulcer severity.
Statistical analysis will include descriptive statistics and multivariable logistic regression to identify independent predictors of pressure ulcer development, adjusting for clinically relevant confounders. The study also aims to explore potential dose-response relationships between IPC exposure duration and risk of injury.
By improving understanding of IPC-associated pressure ulcers, this study seeks to inform safer thromboprophylaxis practices and support the development of monitoring protocols to mitigate preventable harm while preserving the benefits of mechanical venous thromboembolism prevention.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients aged 18 years or older
- Admission to the intensive care unit (ICU) for more than 7 days
- Exposure to intermittent pneumatic compression devices during ICU stay
- Availability of complete electronic medical records, including ICD diagnostic -coding and clinical documentation
Exclusion Criteria:
- Presence of pressure ulcer at the time of ICU admission
- ICU stay shorter than 7 days
- Missing or incomplete clinical data relevant to study variables
- Severe dermatologic conditions affecting skin integrity
- Limb amputation or conditions preventing IPC use
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients with Pressure Ulcer
Patients admitted to the intensive care unit (ICU) for more than 7 days who received intermittent pneumatic compression therapy and developed a pressure ulcer during hospitalization, identified using ICD diagnostic codes and clinical documentation.
Pressure ulcers were classified according to the NPUAP staging system where available.
This cohort will be compared with patients exposed to intermittent pneumatic compression who did not develop pressure ulcers to evaluate associated risk factors.
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Patients without Pressure Ulcer
Patients admitted to the intensive care unit (ICU) for more than 7 days who received intermittent pneumatic compression therapy and did not develop pressure ulcers during hospitalization, identified through ICD codes and clinical records.
This group serves as the reference cohort for comparison of clinical characteristics and risk factors associated with pressure ulcer development.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pressure ulcer incidence
기간: During prolonged ICU stay (>7 days)
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Occurrence of a new pressure ulcer during ICU stay in patients exposed to intermittent pneumatic compression, identified using ICD codes and clinical documentation
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During prolonged ICU stay (>7 days)
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Incidence of Pressure Ulcer
기간: During prolonged ICU stay (>7 days)
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Development of a new pressure ulcer during hospitalization in patients admitted to the intensive care unit (ICU) for more than 7 days and exposed to intermittent pneumatic compression devices.
Pressure ulcers will be identified using ICD diagnostic codes and confirmed by clinical documentation, and classified according to the NPUAP staging system when available.
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During prolonged ICU stay (>7 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Risk factors for pressure ulcer development
기간: Baseline
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Association between patient characteristics and risk of developing pressure ulcers during ICU stay, including age, BMI, diabetes, vasopressor use, immobility, and duration of intermittent pneumatic compression
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Baseline
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Kim JY, Lee YJ; Korean Association of Wound Ostomy Continence Nurses. Medical device-related pressure ulcer (MDRPU) in acute care hospitals and its perceived importance and prevention performance by clinical nurses. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):51-61. doi: 10.1111/iwj.13023.
- Lachmann EA, Rook JL, Tunkel R, Nagler W. Complications associated with intermittent pneumatic compression. Arch Phys Med Rehabil. 1992 May;73(5):482-5.
- Spear M. Pressure ulcer staging-revisited. Plast Surg Nurs. 2013 Oct-Dec;33(4):192-4. doi: 10.1097/PSN.0000000000000015. No abstract available.
- Won SH, Lee YK, Suh YS, Koo KH. Extensive bullous complication associated with intermittent pneumatic compression. Yonsei Med J. 2013 May 1;54(3):801-2. doi: 10.3349/ymj.2013.54.3.801.
- Nouh T, Alsabahi T, Altoijry A, Altuwaijri T. Can intermittent pneumatic compression cause compartment syndrome? Saudi J Anaesth. 2018 Jul-Sep;12(3):488-490. doi: 10.4103/sja.SJA_191_18.
- Skillman J, Thomas S. An audit of pressure sores caused by intermittent compression devices used to prevent venous thromboembolism. J Perioper Pract. 2011 Dec;21(12):418-20. doi: 10.1177/175045891102101203.
- Campbell C, Parish LC. The decubitus ulcer: facts and controversies. Clin Dermatol. 2010 Sep-Oct;28(5):527-32. doi: 10.1016/j.clindermatol.2010.03.010.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ASMC 31-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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