跳至主要内容
临床试验/NCT06966947
NCT06966947已完成不适用

The Positive Impact of Risk Early Warning Management on Postoperative Rehabilitation Quality and Incidence of Delirium in Patients With Hip Fractures

People's Hospital Affiliated to Hubei University of Medicine1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2023年1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
284
试验地点
1
主要终点
Change in Prothrombin Time (PT)

研究概览

简要总结

This clinical study aims to evaluate the effectiveness of a perioperative risk early warning management strategy in patients undergoing surgical treatment for hip fractures. Hip fractures are common in elderly individuals and are associated with a high risk of postoperative complications. Traditional perioperative care may not sufficiently identify and respond to early signs of clinical deterioration.

In this study, patients with hip fractures admitted to the orthopedic department of a single hospital from January 2023 to December 2023 were divided into two groups based on their admission time. Patients admitted between June and December 2023 received the early warning risk management intervention (experimental group), while those admitted between January and May 2023 received routine perioperative care (control group). The early warning management system involved a scoring-based approach using vital signs such as heart rate, respiratory rate, blood pressure, body temperature, and consciousness level to classify patients' risk levels. Nursing staff responded with graded interventions, including enhanced monitoring and rapid physician notification for higher-risk patients.

The study retrospectively enrolled 284 patients in total, with 142 in each group. The primary outcomes include changes in coagulation function, self-care ability (measured by the Exercise of Self-care Agency Scale, ESCA), and hip joint functional recovery (measured by the Hospital for Special Surgery, HSS, score). Secondary outcomes include patient satisfaction and incidence of postoperative complications.

The central hypothesis is that perioperative risk early warning management will improve patient safety, enhance self-care capacity, reduce complications, and promote better recovery outcomes compared to routine care.

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

  • •Diagnosed with unilateral intertrochanteric fracture of the femur confirmed by imaging.
  • •Age 18 years or older.
  • •Met the indications for surgical treatment and underwent fracture surgery in the study hospital.
  • •Stable vital signs and clear consciousness postoperatively.

排除标准

  • •Presence of hematologic diseases such as coagulation dysfunction.
  • •Existing lower limb disability, invasive trauma, or other comorbid lesions.
  • •History of mental disorders, cognitive impairment, or poor compliance with treatment protocols.

结局指标

主要结局

Change in Prothrombin Time (PT)

时间窗: Preoperative baseline and Postoperative 3 days

Prothrombin Time (PT) will be measured in seconds using a standardized coagulation analyzer to evaluate the extrinsic coagulation pathway. Preoperative and postoperative PT values will be compared between the intervention and control groups.

Change in Activated Partial Thromboplastin Time (APTT)

时间窗: Preoperative baseline and Postoperative 3 days

Activated Partial Thromboplastin Time (APTT) will be measured in seconds to assess the intrinsic coagulation pathway. Preoperative and postoperative APTT values will be compared between groups.

Change in Fibrinogen (FBG) Levels

时间窗: Preoperative baseline and Postoperative 3 days

Fibrinogen levels (g/L) will be quantified to reflect clotting factor concentration. Preoperative and postoperative FBG values will be compared between groups.

Change in D-Dimer (D-D) Levels

时间窗: Preoperative baseline and Postoperative 3 days

D-dimer levels (mg/L) will be measured to evaluate fibrinolysis activity. Preoperative and postoperative D-D values will be compared between groups.

次要结局

  • Change in Exercise of Self-Care Agency Scale (ESCA) Score(Baseline (pre-intervention) and immediately after the intervention)
  • Incidence of Postoperative Complications(Perioperative period to 30 days after Endpoint (day of discharge))
  • Patient Satisfaction Rate(Immediately after the intervention)

研究者

发起方
People's Hospital Affiliated to Hubei University of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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