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临床试验/NCT04563858
NCT04563858已完成不适用

Interdisciplinary Treatment Towards a Patient With Delirium

Andrzej Frycz Modrzewski Krakow University1 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2020年5月22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
444
试验地点
1
主要终点
Reliability for the Polish version 4AT

研究概览

简要总结

Delirium is a phenomenon which affects patients with various disorders and representing various age groups. Screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. The aim of the study is to examine the reliability and validity of the Polish version of the 4AT (Pol4-AT) in patients after cardiac surgery.

Procedure of validation:

After obtaining the author's consent, the original English version of the 4AT was separately translated by 3 centres working on the validation of the Pol4-AT (University of Rzeszów, Poland; University Hospital in England; Karolinska University, Sweden). Then, three translations were compared, to be approved by the project supervisor (Karolinska University). Any doubts arising during the comparison were consulted with the English translator. As a result, one coherent version was accepted and translated back into English. The questionnaire was distributed in a convenient sample of 20 patients to examine the validity of the face. Vague words and statements were changed, and the final version translated into Polish was created. The Pol4-AT was tested for internal consistency and reliability.

详细描述

Delirium, which generally is triggered by underlying medical conditions, is an acute and fluctuating disorder associated with attention and cognitive defects, and frequently accompanied by excessive arousal and perception-related problems. Delirium may lead to a variety of complications, e.g. cognitive impairments. Development of delirium is promoted by both anaesthesia and pain. Patients subjected to cardiac surgeries are at risk of delirium due to such factors as extracorporeal circulation applied during the intervention and various cardiovascular complications. Rapid identification of the problem may help eliminate avoidable complications which can be prevented at an early stage.

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

入选标准

  • able to sign the consent form
  • elective cardiac surgery
  • extracorporeal circulation

排除标准

  • unconscious patients
  • diagnosed mental illness
  • patient's lack of consent to participate in the study

结局指标

主要结局

Reliability for the Polish version 4AT

时间窗: third day following a surgery

The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course. A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.

Validity for the Polish version 4AT

时间窗: third day following a surgery

The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course. A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.

次要结局

未报告次要终点

研究者

发起方
Andrzej Frycz Modrzewski Krakow University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucyna Tomaszek

Principal Investigator

Andrzej Frycz Modrzewski Krakow University

研究点 (1)

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