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临床试验/NCT04146727
NCT04146727Unknown不适用

Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
168
试验地点
1
主要终点
Daily ambulation

研究概览

简要总结

The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.

Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.

The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.

详细描述

Early mobilization of patients, minimizing sedatives, maximizing pain control, optimizing sleep are strongly associated with decreased rates of delirium, decreased ICU length of stay, decreased hospital length of stay as well as improved functional status and quality of life at 1 year. Cardiac surgical patients that are at high risk of prolonged stay in the ICU due to the inherent nature of their disease (ie need for MCS (mechanical circulatory support) or lung transplantation) are most likely to benefit from a systematic aggressive approach to early mobilization. Technology such as activity trackers and virtual reality have been studied in general surgical populations but with limited data in the ICU and to date no studies in a cardiac surgical population. Activity trackers utilized in a multidisciplinary team to provide objective data to care teams and patients can be used to develop goal setting and patient motivation for teams, thereby improving mobility

Overall Goal: To evaluate whether quantitative information on post procedural ambulation in mechanical device patients, cardiac surgical patients and lung transplant patients can improve care teams ability to monitor and identify patients at high risk for complications and prolonged length of stay.

  • The purpose of the research is to improve mobility in the perioperative period using Activity Trackers to augment current practice.
  • Objective quantification and improvement in activity of post cardiac surgery patients might result in improved clinical outcomes, thereby making this tool a part of routine practice.

Patient Populations:

  1. Lung transplant patients
  2. Routine postoperative Cardiac surgical patients (elective cardiac surgical procedures including CABG and Valve replacement)
  3. Device Patients (axillary patients pre-open heart transplantation (OHT). Post MCS patients)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients that are at high-risk patients for one of the following interventions, will be considered for this study:
  • Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
  • MCS patients post procedure including TAH, LVADs
  • Lung Transplant patients
  • Subjects > 18 years of age.
  • Ability to provide informed consent and follow-up with protocol procedures

排除标准

  • Non-ambulatory patients
  • Participation in an on-going protocol studying an experimental drug or device
  • Use of a walker, cane or wheelchair at baseline
  • Inability to wear the biosensor on the wrist
  • Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study

结局指标

主要结局

Daily ambulation

时间窗: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment

Steps taken

Length of Stay

时间窗: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment

Days until Discharge to a transitional care facility vs. home

Admit again to ICU

时间窗: From date of inclusion until event or 30 days post enrollment

Readmissions to an ICU or hospital

次要结局

未报告次要终点

研究者

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

Anahat Dhillon

Staff Physician II

Cedars-Sinai Medical Center

研究点 (1)

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