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临床试验/NCT05588271
NCT05588271招募中不适用

Establishment of Risk Prediction Model for Pressure Injury in Patients Undergoing Liver Transplantation and Development of Prediction Tool

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2022年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
1
主要终点
According to The National Pressure Ulcer Advisory Panel (NPUAP) defined the definition and stage of Pressure Injury to Judge whether pressure injury occurs on skin under pressure.

研究概览

简要总结

Pediatric population is at a high-risk of pressure injury (PI). Patients undergoing liver transplantation are more prone to PIs compared with other types of surgery. However, there is a lack of sensitive and specific assessment tools for the risk of PI in patients undergoing liver transplantation. How to accurately predict the incidence of PI in patients undergoing liver transplantation is needs to be urgently eliminated. The study is conducted in the Renji Hospital, School of Medicine, Shanghai Jiaotong University which is the largest liver transplantation center in China.

详细描述

Data of 1200 eligible patients undergoing liver transplantation between July 2018 and June 2021 are selected.The sample size was randomly divided into 70% discovery set and 30% validation set according to 7:3. 70% of the discovery dataset are used for the establishment of risk prediction model. The univariate analysis is used to evaluate PI-associated risk factors. In addition, a multivariate logistic regression model is developed using selected variables and P<0.05 in the univariate analysis is used to identify independent risk factors for PIs. The odds ratio for each independent variable is determined with a 95% confidence interval. Finally, a nomogram of predictive model is generated on the basis of the results of multivariate analysis.Discrimination capability, calibration degree, and clinical value will be used to verify the efficacy of the prediction model. This study develops and validates a prediction model for predicting the risk of PI in patients undergoing liver transplantation. Using this prediction model, we will develop decision-support systems to prevent PI in the future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • undergoing liver transplantation surgery (i.e., living-donor liver transplantation and deceased donor liver transplantation)
  • patients undergoing the first surgery during their hospitalization

排除标准

  • a history of PI before undergoing surgery
  • patients with skin disease that could affect observation of skin and the outcome
  • patients who died during surgery

结局指标

主要结局

According to The National Pressure Ulcer Advisory Panel (NPUAP) defined the definition and stage of Pressure Injury to Judge whether pressure injury occurs on skin under pressure.

时间窗: Within 6 hours after operation

Definition:A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue. NPUAP Pressure Injury Stages:stage 1pressure injury: non-blanchable erythema of intact skin; stage 2 pressure injury: partial-thickness skin loss with exposed dermis; stage 3 pressure injury: full-thickness skin loss; stage 4 pressure injury: full-thickness skin and tissue loss; unstageable pressure injury: obscured full-thickness skin and tissue loss; deep tissue pressure injury: persistent non-blanchable deep red, maroon or purple discoloration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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