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临床试验/NCT07153380
NCT07153380已完成不适用

Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Emotional distress

研究概览

简要总结

Emotional distress is prevalent in ICU patients and may be influenced by physical symptoms such as dyspnea and pain, yet its evolution and interactions during ICU stay remain insufficiently explored. The main objective of this study is to investigate the trajectory of anxiety, sadness, dyspnea, and pain during ICU stay, as well as their associations with clinical and demographic factors. Moreover, the investigators will study the impact of emotional distress during ICU admission in the cognitive status of the ICU survivors at discharge.

In this study the investigators will recover the data of 62 ICU patients who participated in 3 different studies lead by the research line of Characterization and Managment of the Post-Intensive Care Syndrome from the I3PT research Group of Translational Research in the Physiopathology of the Critically Ill Patients. In the 3 studies, emotional distress (anxiety and sadness), dyspnea, and pain were evaluated daily using visual analog scales once adequate consciousness was achieved (RASS -1 to +1). Cognitive status at ICU discharge was assessed using the Montreal Cognitive Assessment (MoCA). The datasets of the 3 studies will be revised and a new database will be generated with participants who have an assessment of emotional distress for at least 80% of the ICU length of stay with an optimal level of consciousness (RASS >-1). New mixed-effects models will be used to explore the evolution of emotional and physical distress during ICU admission and the associations with invasive mechanical ventilation (IMV), and other demographic and clinical variables. Expected results: the investigators expect a better understanding of the evolution of anxiety and sadness symptoms during ICU stay and its relationship with the level of dyspnea and pain experienced by the critically ill patients during admission.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥ 18 years old
  • •Admitted to the ICU for at least ≥ 24 hours

排除标准

  • •Previous cognitive impairment or dementia
  • •Prior history of neurological disease (including brain damage at admission)
  • •Severe psychiatric disorder (including substance use disorder)
  • •Intellectual disability
  • •Non-Spanish speaker
  • •Life expentancy <12 months
  • •Refusal to participate in the study.

结局指标

主要结局

Emotional distress

时间窗: During ICU admission

Daily levels of anxiety and depression symptoms- Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).

Physical distress

时间窗: During ICU admission

Daily levels of dyspnea and pain. - Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).

次要结局

  • Cognitive status(From the first documented data on discharge from the ICU for the first subject included in the study, to the last documented data on discharge from the ICU for the last patient included in the study, evaluated up to 24 months.)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabet Doña-López

Researcher

Corporacion Parc Tauli

研究点 (1)

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