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临床试验/NCT04270331
NCT04270331已完成不适用

Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study

Mahidol University1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2020年4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
已完成
入组人数
509
试验地点
1
主要终点
ICU free days

研究概览

简要总结

The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

详细描述

Pain is frequently reported in patients admitted to an ICU, with an incidence of up to 50% in medical patients during admission, and increasing up to 80% during standard care procedures. Agitation was also reported in 52% of the patients, typically within 4-9 days after admission. However, there were studies reporting inadequate pain, agitation and delirium assessment and management in real-world clinical practice. The clinical practice guideline for the management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU was recently published in 2018 and emphasized routinely monitoring pain, agitation and delirium during ICU admissions. Also, appropriate management of pain and agitation in critically ill patients resulted in reduction in ICU length of stay, hospital length of stay, delirium and mortality. Therefore, structural pain, agitation/sedation, delirium assessment and treatment in the ICUs, Thailand might be necessary.

Since pain, agitation/sedation and delirium protocol has not yet been initiated in ICUs, Thailand, this study is designed as a before-after study in order to assess outcomes by comparing between before and after protocol initiation. The objectives of the study were to document the impact of pain, agitation/sedation, delirium protocol on clinical outcomes of ICU patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
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
否

入选标准

  • •Adults (18 years and older)
  • •Patients admitted to medical or surgical intensive care units

排除标准

  • •Terminal ill patients, or patients unlikely to survive > 24 hours

研究组 & 干预措施

A Before group

No Intervention

No protocol assigned

An After group

Experimental

PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned

干预措施: PADS protocol (Other)

结局指标

主要结局

ICU free days

时间窗: During ICU stay or death or a maximum of 28 days

Days alive and not stay in ICU

次要结局

  • Non-benzodiazepines use(During ICU stay or death or a maximum of 28 days)
  • Benzodiazepines use(During ICU stay or death or a maximum of 28 days)
  • Mechanical ventilator free days(During ICU stay or death or a maximum of 28 days)
  • Delirium free days(During ICU stay or death or a maximum of 28 days)
  • Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement(During ICU stay or death or a maximum of 28 days)
  • Incidence of in-target pain, agitation/sedation, delirium(During ICU stay or death or a maximum of 28 days)
  • Compliance to PADS protocol(During ICU stay or death or a maximum of 28 days)
  • All-cause hospital mortality(During hospital stay or death or a maximum of 90 days)
  • Antipsychotics use(During ICU stay or death or a maximum of 28 days)

研究者

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

Pitchaya Dilokpattanamongkol

Lecturer

Mahidol University

研究点 (1)

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