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临床试验/CTRI/2024/06/068532
CTRI/2024/06/068532已完成不适用

Feasibility and impact of the Home in ICU concept, an interventional pilot study in a tertiary care medical college hospital of Eastern India

Kondala Swathi1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Feasibility

研究概览

简要总结

This study is a single-centered non-randomized interventional pilot trial to assess the feasibility of practicing the ‘home at ICU’ concept and its superiority over conventional intensive care. The primary outcome measures will be the feasibility of the ’Home in ICU’ care, ICU length of stay, and the presence of delirium on admission, during ICU stay, and at discharge. Also, bedsores and ICU-acquired infections at discharge will be noted. The secondary outcome will be burnout symptoms, workload among nurses and doctors,  and patient well-being assessed using questionnaires. Others will be incidences of near-miss events, time taken to ask for consent, and time to obtain consent.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • For patients 1.Willing to participate in the study 2.Conscious, alert, and able to communicate For family members 1.Close family member 2.The patient is willing for the family member to stay with them 3.Sensible and effective 4.Emotionally stable 5.Willing to participate in the study 6.Trained in ‘Home in ICU’ care 7.Willing to stay for at least 7 days during ICU stay with the patient after training and assessment For healthcare team 1.Willing to participate in the study.

排除标准

  • Diagnosed with a serious airborne contagious disease (Covid 19, H1N1)
  • Anybody who is not meeting the inclusion criteria.

结局指标

主要结局

Feasibility

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

Patient satisfaction during ICU stay whenever possible

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

ICU length of stay

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

Presence or absence of delirium

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

Occurrence of near-miss events during ICU stay

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

Post-discharge cognition impairment using BASIC- Q scoring system

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

Occurrence and severity of bedsore

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

ICU-acquired infections

时间窗: Feasibility - ICU discharge | Patient satisfaction during ICU stay whenever possible- Daily | ICU length of stay- ICU discharge | Presence or absence of delirium- 8th hrly | Occurrence of near-miss events during ICU stay- Daily | Post-discharge cognition impairment using BASIC- Q scoring system - Day 28 | Occurrence and severity of bedsore -daily | ICU-acquired infections- daily

次要结局

  • Incidence & level of burnout symptoms & workload among nurses & doctors using questionnaires

研究者

发起方
Kondala Swathi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kondala Swathi

IMS and SUM Hospital

研究点 (1)

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