跳至主要内容
临床试验/NCT06069349
NCT06069349招募中不适用

The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study

Jingyuan,Xu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
duration of delirum

研究概览

简要总结

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

详细描述

The prevalence of cardiac diseases is high, as the standard treatment for many heart diseases, a bunch of strategies are performed to improve the outcome of cardiac surgery.

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • > 18-year-old postoperative cardiac patient admitted to ICU, the time < 24h
  • Patients agree to participate in clinical research and sign informed consent before the start of the study

排除标准

  • Patients who meet any of the following criteria are not eligible for inclusion in this study:
  • Pregnant and lactating women
  • There are contraindications to getting out of bed:
  • 2.1 Low cardiac output syndrome
  • (1) Application of IABP or PCPS (percutaneous cardiopulmonary support)
  • (2) High doses of vasoactive drugs (norepinephrine> 0.5ug/kg.min)
  • (3) SBP<=80mmHg
  • (4) Acrocyanosis, wet and cold
  • (5) Metabolic acidosis
  • (6) Urine output less than 0.5ml/kg.h for more than 2 hours
  • 2.2 Heart rate greater than or equal to 120 beats per minute at rest
  • 2.3 Orthostatic hypotension (systolic blood pressure less than 80 mmHg after postural change)
  • 2.4 Presence of arrhythmias leading to a drop in blood pressure (e.g., decreased blood pressure due to new-onset atrial fibrillation)
  • 2.5 Difficulty breathing at rest or respiratory rate greater than 30 breaths per minute
  • 2.6 Postoperative bleeding (200ml in 2-3 hours)

结局指标

主要结局

duration of delirum

时间窗: 7 days

The duration of delirum in hours

次要结局

  • hospital length of stay(hospital length of stay, approximately 10 days)

研究者

发起方
Jingyuan,Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jingyuan,Xu

Deputy Chief Physician

Southeast University, China

研究点 (1)

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