Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.
详细描述
To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 75 years old;
- •Patients with hip fracture purely and surgical treatment is scheduled.
排除标准
- •Surgical treatment has been performed after entering hospital;
- •Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
- •Refuse to sign informed consent;
- •Investigator thinks he/she is inappropriate to carry out this study.
研究组 & 干预措施
New "guideline"
New "guideline" anesthesia strategy team (Group A)
干预措施: New "guideline" anesthesia strategy team (Procedure)
Current strategy
Current anesthesia strategy team (Group B)
结局指标
主要结局
Mortality
时间窗: 6 months after surgery
Mortality in 6 months of postoperative
次要结局
- Visual Analogue Score(VAS)(within two days after surgery)
- MMSE(Two days after surgery)
- Compliance score(Duration of hospital stay, an average of 2 weeks)
- Hospital stay(Up to discharge,an average of 2 weeks)
- Satisfaction score(Two weeks before discharge)
- Complications(post-operation to discharge, an average of 2 weeks)
- Death rate(Within 30 days and 1 year after surgery)
- Cost(Length of hospital stay,an average of 2 weeks)
- Survival time(up to one year after surgery)