Decreasing Delirium Through Music in Critically Ill Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Days Free of Delirium and Coma
研究概览
简要总结
Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.
详细描述
One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia.
Recent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or older.
- •English speaking.
- •Admitted to the intensive care unit (medical or surgical).
- •Expected mechanical ventilator support for ≥48 hours.
- •Consentable through a legally authorized representative.
- •Have access to a telephone.
排除标准
- •History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
- •Psychiatric illness which is not well controlled.
- •Alcohol withdrawal symptoms/concern for withdrawal.
- •Suspected or confirmed drug intoxication/overdose
- •Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
- •Uncorrected hearing or vision impairment including legal blindness.
- •Incarcerated at the time of study enrollment.
- •Enrolled in another clinical trial which does not permit co-enrollment.
- •Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.
结局指标
主要结局
Days Free of Delirium and Coma
时间窗: Seven day study intervention phase
Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase.
次要结局
- Anxiety(3 months post hospital discharge)
- Cognition(3 months post hospital discharge)
- Depression(3 months post hospital discharge)
- Cognition(3 months post hospital discharge)
- Delirium Severity(Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.)
- Pain Intensity(4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.)
- Anxiety(3 months post hospital discharge)
- Depression(3 months post hospital discharge)
研究者
Babar Khan, MD, MS
Associate Professor of Medicine
Indiana University