跳至主要内容
临床试验/NCT04203953
NCT04203953已完成不适用

Impact of a Quality Improvement Intervention to Promote Early Mobilization in Patients in the Trauma ICU

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年12月3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
42
试验地点
1
主要终点
the proportion of patients with OT and/or PT consultations by ICU

研究概览

简要总结

Background: Despite the fact that many lines of evidence point to the safety and feasibility of early mobilization in medical or surgical ICUs, there remains limited evidence regarding the efficacy or outcome of mobilizing patients in trauma ICU. Given the lack of published literature or routine protocol for mobilizing this population in our institution, the investigators developed a formal protocol and quality improvement project.

Objective: To determine the flexibility and effects of an early mobilization project in a trauma ICU.

Design: Observational, pre-post design.

Setting: A eight-bed trauma ICU in a medical center in Taipei.

Patients: Critically ill adults admitted to the trauma ICU.

Intervention: This project will involve a routine care baseline phase to promote early mobilization of critically ill patients. The bedside physical therapist (PT) will assess the appropriateness of the activity level throughout the day. The PT will provide guidelines for appropriate activities, with the option to perform more advanced activities using equipment. Early mobilization will be provided once daily 5 days/week during the 30-minute family visiting time.

Outcome: The primary outcome measures will be as follows: (1) the proportion of patients with occupational therapist (OT) and/or PT consultations per ICU days 3, 7 and 14; (2) the time and types of mobilization activities performed at the day of ICU admission, the day of ICU discharge and the day of hospital discharge, including passive and active activities; (3) the Perme intensive care unit mobility score at the day of ICU admission, the day of ICU discharge and the day of hospital discharge; Secondary outcome measures will include the following: (1) the number of times and reasons for suspended activities; (2) mobilization-related adverse events.

Statistical Analysis: Unadjusted comparisons before and after implementation of the project will be performed using chi-square analysis, Fisher exact test, or the Wilcoxon signed rank test, as appropriate. A two-sided p-value less than 0.05 will be used to determine statistical significance.

详细描述

Background:

Early mobilization is a component of the ABCDE bundle (Awaken from sedation; Breathe independently from ventilator; Choice of sedation; Delirium management; Early mobilization), an interdisciplinary, patient-centered strategy to facilitate evidence-based practices in intensive care unit (ICU) settings. In patients who underwent early mobilization, specific benefits were fewer ventilator days, fewer ICU and hospital days, fewer hospital complications, less sedation and delirium days, and improved in-hospital functional outcomes. Despite the fact that several lines of evidence demonstrated the safety and efficacy of early mobilization in the ICU, studies conducted in neurological or trauma ICU settings are scarce, possibly because of safety considerations such as physiologic instability (hemodynamic or intracranial pressure) and invasive device integrity. It has only recently been suggested that such programs are effective, safe, and potentially beneficial in critically ill neurological patients. Nevertheless, there is no set protocol in place for moving these patients, nor any suggested parameters to monitor.

Evidence regarding early mobilization has been based on reports from general medical and surgical ICU environments, rather than from neurosurgical ICU (NSICU) or trauma ICU settings. In NSICU patients with acute brain injury mostly, safety during mobilization could be compromised because of hemiparesis or hemiplegia, cognitive impairment, tenuous intracerebral pressure and cerebral perfusion, or dislodgement of cerebral monitoring or other indwelling devices. In trauma ICU, trauma patients often have extensive orthopedic and neurosurgical injuries, creating additional barriers to mobility. Little is known about the potential effects of mobilizing patients with acute brain or server injuries admitted to the trauma ICU. In one pre- and post-intervention research study of early mobilization in patients with neurologic injury treated in a ICU, mobility levels increased post-intervention, without adverse events. The results also supported the notion that progressive early mobilization program leads to shorter ICU and hospital length of stay (LOS), fewer patient restraint days, and fewer hospital-acquired infections. Another relevant study showed that implementation of a progressive mobility algorithm was safe and was associated with a higher likelihood of mobilization in the first week after spontaneous intracerebral hemorrhage (ICH) in the neurological ICU. For trauma patients, previous studies demonstrated the safety of a mobility protocol in a trauma and burn ICU and, additionally, showed a decrease in airway, pulmonary, and vascular complications. Results from another study revealed favorable functional outcomes for patients involved in a structured mobility program with physical therapy in the neuro/trauma ICU. Overall, the lack of available evidence highlights the fact that there remains much research to be done regarding early rehabilitation for patients in the trauma ICU and there are specific questions to be answered regarding the timing of intervention, the intensity and the type of exercises.

Previously, in the trauma ICU of National Taiwan University Hospital (NTUH), the referral of patients for physical therapy and mobilization occurred at the discretion of the medical providers with very low the proportion of patients with physical therapist (PT) consultations. Therefore, the overall objective of this quality improvement (QI) project will be to evaluate a structured and interdisciplinary early rehabilitation and progressive mobility protocol for critically ill patients in a trauma ICU.

Purpose: The goals of the project will be to provide a standardized, evidence-based, interdisciplinary mechanism to increase each patient's activity level safely while simultaneously initiating and promoting a culture of mobility. The investigators will also conduct this project to evaluate the effects of this early mobilization program on the outcomes of patients in the trauma ICU.

研究设计

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

入排标准

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

入选标准

  • patients >20 years of age admitted to the trauma ICU (more than 3 days)
  • who were alive more than 7 days after ICU admission

排除标准

  • patients < 20 years old who required trauma ICU admission for less than three days
  • died after ICU admission
  • Glasgow Coma Scale (GCS) < 6
  • raised intracranial pressure>20mmHg
  • with cardiopulmonary arrest
  • with acute myocardial infarction
  • with rapidly developing neuromuscular disease
  • with pregnancy
  • with ruptured or leaking aortic aneurysm
  • ICU admission for palliative care or medical orders specifying alternate activities.

结局指标

主要结局

the proportion of patients with OT and/or PT consultations by ICU

时间窗: up to 1 year

on days 3, 7 and 14 after onset

the time mobilization activities performed in the ICU

时间窗: up to 1 year

on the day of ICU admission, the day of ICU discharge and the day of hospital discharge

the types of mobilization activities performed in the ICU

时间窗: up to 1 year

on the day of ICU admission, the day of ICU discharge and the day of hospital discharge. The activities including passive and active activities.

the Perme intensive care unit mobility score

时间窗: up to 1 year

on the day of ICU admission, the day of ICU discharge and the day of hospital discharge. The Perme ICU Mobility Score ranges from 0 to 32. The score is derived from 15 items grouped in 7 categories: mental status, potential mobility barriers, functional strength, bed mobility, transfers, gait, and endurance. The score uses a maximum range of 2 to 4 points for each of the 15 items, and it provides a total score that reflects the patient's mobility status at one particular moment in time. A high score indicates few potential mobility barriers and decreased assistance whereas a low score indicates more potential barriers to mobility and more assistance needed for mobility.

次要结局

  • the number of times that activities were stopped(up to 1 year)
  • the reasons that activities were stopped(up to 1 year)
  • mobilization-related adverse events(up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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