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临床试验/CTRI/2024/03/063517
CTRI/2024/03/063517尚未招募不适用

Serial transcranial Doppler velocity measurement as a screening tool for delirium in decompensated heart failure patients admitted to Cardiac ICU.

Dr Vimal Bhardwaj1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
327
试验地点
1
主要终点
To explore if serial transcranial blood flow velocity measurement by a bedside ultrasound Doppler

研究概览

简要总结

Delirium is a serious medical disorder diagnosed in hospitalized patients, especially in ICU.  Its incidence in the cardiac ICU is 15-20%. Diagnosis of delirium in the ICU is crucial since it has been associated with increased days on ventilator, prolonged

hospitalization with associated increased costs and mortality.

The use of a bedside transcranial Doppler to measure the middle cerebral artery (MCA) blood flow velocities in delirium has been reported. Caplan et al reported that MCA flow velocities measured through a transcranial Doppler could be a potential diagnostic and a monitoring tool for delirium superimposed on dementia.

However, the sample size in these studies were small. Hence, we propose to study the efficacy of TCD measured MCA velocities to predict delirium in decompensated heart failure patients admitted to ICU. We also aim to explore the association of degree of venous congestion (assessed by VExUS) with delirium.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All ICU patients aged more than 18 years admitted with decompensated heart failure with the any one of the following: 1.Not requiring invasive mechanical ventilation 2.Intubated patients with RASS score of more than -3 3.Patients in shock with Vasoactive inotropic score less than 5.

排除标准

  • Patient or the primary caregiver not giving consent.
  • Patients with poor transcranial window
  • Patients with abnormal findings on brain imaging, if available
  • Patients with PaO2 less than 60mm hg on the day of TCD screening.
  • PaCO2 less than 32mm hg or more than 45mm hg on the day of TCD screening.
  • Past history of cognitive disorders
  • Previous or current Stroke/intracranial bleeding
  • Hypothermia with core body temperature less than 34 degree celsius on the day of TCD screening.
  • Hypertension with blood pressure more than 180/110 mm hg during TCD screening.
  • Hypotension with mean arterial pressure less than 60 mm hg during TCD screening.
  • RAAS Score of more than +2 during TCD screening.

结局指标

主要结局

To explore if serial transcranial blood flow velocity measurement by a bedside ultrasound Doppler

时间窗: Until in ICU

can be used as a screening tool to predict delirium in decompensated heart failure patients admitted to cardiac ICU.

时间窗: Until in ICU

次要结局

  • To determine if abnormal VExUS scores are associated with a higher risk of delirium.(Until in ICU)
  • To determine the relationship between VExUS scoring and TCD measurements.(Until in ICU)

研究者

发起方
Dr Vimal Bhardwaj
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Vimal Bhardwaj

Narayana Health

研究点 (1)

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