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临床试验/NCT02856737
NCT02856737撤回不适用

Reducing Delirium in the Surgical Intensive Care Unit Through the Use of Eye Masks and Earplugs

Boston Medical Center1 个研究点 分布在 1 个国家开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Sedative use

研究概览

简要总结

Delirium is an acute disturbance in mental abilities and confusion that affects many patient in the hospital and is caused by multiple factors including and altered sleep/wake cycles and multiple sedating medications. Patients in the ICU are particularly susceptible to developing delirium due to increased noise levels and metabolic derangements.

Numerous studies have shown that delirium can be associated with many negative outcomes, including longer hospital length of stay, increased time on a ventilator, higher mortality rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological interventions that have been shown to reduce delirium especially in intensive care units. These include noise reduction, frequent reorientation, reducing unnecessary stimulation at night, and grouping patient care procedures.

The aim of this study is to evaluate the benefits of eye masks and earplugs (used concurrently) on reducing delirium and to assess for associated outcomes such as length of stay, use of sedating medications, morbidity, and mortality. The benefits of this are to improve sleep quality, and this intervention has been associated with a reduction in the risk of delirium.

详细描述

Delirium is an acute disturbance in mental abilities and confusion that affects many patient in the hospital and is caused by multiple factors including and altered sleep/wake cycles and multiple sedating medications. Patients in the ICU are particularly susceptible to developing delirium due to increased noise levels and metabolic derangements.

Numerous studies have shown that delirium can be associated with many negative outcomes, including longer hospital length of stay, increased time on a ventilator, higher mortality rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological interventions that have been shown to reduce delirium especially in intensive care units. These include noise reduction, frequent reorientation, reducing unnecessary stimulation at night, and grouping patient care procedures.

The aim of this study is to evaluate the benefits of eye masks and earplugs on reducing delirium and to assess for associated outcomes such as length of stay, use of sedating medications, morbidity, and mortality. The benefits of this are to improve sleep quality, and this intervention has been associated with a reduction in the risk of delirium.

Detailed Description: Patients eligible for this study will include patients admitted to either the Surgical ICU (SICU) or stepdown unit, under the care of the SICU care team, beginning on 8/1/16. Consent will be obtained from patients or their family members by study personnel. Data that will be collected include diagnosis on admission, any surgeries performed and their respective dates, length of stay in the SICU and step-down unit, use of sedating medication, and the Confusion Assessment Method (CAM) results. Subjects will also be asked to fill out 2 separate questionnaires about the quality of their sleep. The first questionnaire will be administered on enrollment and the second questionnaire will be administered upon discharge from the SICU. The rates of compliance of the use of earplugs and eye masks will also be assessed by means of a calendar checklist to be displayed at the patient's bedside.

These outcomes will be compared to those of a historical control group not undergoing such interventions. The investigators aim to enroll 100 subjects and have a control group of another 100 patients retrospectively selected from matched patients over the previous year (8/1/15 - 8/1/16), before implementation of such interventions. The remainder of patient data will be collected by means of a retrospective chart review.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Patient spending more than or equal to 24 hours in the SICU or stepdown unit

排除标准

  • •Known pre-existing history of sleep pathology, severe visual or hearing impairment
  • •History of cognitive dysfunction (dementia, traumatic brain injury, stroke or hepatic encephalopathy, or intellectual disability)
  • •Admitted in delirious state
  • •Facial trauma involving orbits or auditory canals

研究组 & 干预措施

Earplugs and eye masks (to be used concurrently)

Experimental

Group will include patients consented to the use of earplugs and eye masks. Patients will participate in the intervention nightly

干预措施: eye masks and earplugs (Other)

结局指标

主要结局

Sedative use

时间窗: for the duration of a patient's hospital stay (1 day - 1 year)

quantification of sedating medications used during a patient's hospital stay

Length of stay

时间窗: for the duration of a patient's hospital stay (1 day - 1 year)

Delirium

时间窗: for the duration of a patient's hospital stay (1 day - 1 year)

Daily assessment of delirium documented in the patient's chart

CAM-ICU

时间窗: for the duration of a patient's hospital stay (1 day - 1 year)

documentation of the CAM-ICU scoring system for delirium on a daily basis in patient's chart

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

Stephanie Talutis

Fellow in the Study of Quality and Patient Safety

Boston Medical Center

研究点 (1)

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