Single-Center Prospective Observational Cohort Study of Perioperative Point-of-Care Ultrasound and Hemodynamic Status on Postoperative Delirium and Clinical Outcomes in Elderly Patients With Hip Orthopedic Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
About this study
This is a single-center prospective observational cohort study involving older adults undergoing hip surgery. The investigators will collect clinical and ultrasound-related information without changing routine treatment, anaesthesia, or surgical plans. The purpose of this study is to determine whether certain bedside ultrasound measurements and blood-flow status around the time of surgery are associated with postoperative delirium and other patient outcomes.
What is the aim of this study?
Postoperative delirium is a state of sudden confusion that may occur after surgery in older patients. This study focuses on older patients undergoing hip orthopaedic surgery. The investigators aim to explore the relationships between peri-operative bedside ultrasound findings, hemodynamic (blood flow and circulation) status, and the occurrence of postoperative delirium.
The study will focus on several ultrasound measurements, including pre-operative carotid artery plaque burden, corrected flow time of the common carotid artery (FTc), and optic nerve sheath diameter (ONSD). The investigators will assess the associations between these measurements and postoperative delirium, and will further analyse how these factors may influence postoperative prognosis and clinical outcomes.
What will happen in this study?
This is an observational study. No experimental drugs or treatments will be administered to participants. Standard hospital care will not be altered because of participation in this study. Participants aged 65 years or older who are scheduled for hip orthopaedic surgery will be continuously enrolled. Information will be collected in four parts:
Pre-operative assessment (before anaesthesia)
Bedside ultrasound scans will be performed. The investigators will assess carotid artery plaque burden, measure corrected flow time (FTc) of the common carotid artery, and measure optic nerve sheath diameter (ONSD). General background information and existing medical conditions of participants will also be recorded.
Intra-operative monitoring (during surgery)
The investigators will document circulation-related data, including blood pressure, heart rate, oxygen levels, type of anaesthesia, medicines administered, and surgical details, to evaluate changes in circulatory status during the operation.
Post-operative assessment (after surgery)
From postoperative day 1 to postoperative day 5, or until hospital discharge (whichever occurs first), staff members will assess participants daily for signs of postoperative delirium. Clinical outcome information will also be collected, including postoperative complications (such as pneumonia), pain scores, and length of hospital stay.
Data analysis
The investigators will analyse the collected data. The study will examine associations between peri-operative ultrasound and hemodynamic parameters and postoperative delirium. The investigators will evaluate whether these ultrasound measurements can help predict the risk of postoperative delirium and explore relationships between these measurements and postoperative clinical outcomes.
Why is this research being conducted?
By collecting objective peri-operative measurements, the investigators aim to clarify the relationships between these factors, postoperative delirium, and real-world clinical outcomes. Findings from this study may help clinicians better evaluate surgical risks for older adults undergoing hip surgery in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older
- •Scheduled for hip orthopedic surgery, including artificial femoral head replacement for femoral neck fracture, PFNA internal fixation for intertrochanteric fracture, total hip arthroplasty, and other hip-related operations
- •Expected postoperative hospital stay of 3 days or longer
- •Bedside carotid ultrasound and optic nerve sheath diameter (ONSD) measurement can be completed before anesthesia, or can be performed without interfering with clinical treatment as judged by investigators
- •Written informed consent obtained from the patient or their legal representative
排除标准
- •Pre-existing delirium or severe dementia before surgery, which prevents valid cognitive and postoperative delirium assessment
- •Recent acute stroke, intracranial hemorrhage, or other acute neurological emergencies
- •Severe ocular disease, ocular trauma, recent ophthalmic surgery, or other conditions unsuitable for ONSD measurement
- •History of neck surgery, neck injury, dressing coverage, or poor acoustic window that prevents carotid ultrasound examination
- •Immediate postoperative transfer to another hospital, continuous sedation, or endotracheal intubation leading to inability to assess postoperative delirium
- •Refusal to participate in the study or withdrawal of informed consent at any stage
研究组 & 干预措施
Overall Study Cohort
Single-center prospective observational cohort. Consecutive patients aged ≥65 years undergoing hip orthopedic surgery are enrolled. No standard clinical care, anesthesia or surgical management is modified for research. Peri-operative bedside ultrasound and hemodynamic data are collected for observational analysis. Analyzable sample size: 450 subjects. No control arm.
干预措施: Peri-operative observational data collection of bedside ultrasound and hemodynamic parameters (Other)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Postoperative day 1 to postoperative day 5, or prior to hospital discharge (whichever occurs first)
Postoperative delirium will be screened daily by trained research personnel using the Confusion Assessment Method (CAM). A positive CAM assessment at any time point defines postoperative delirium. This outcome will be used to assess associations between preoperative ultrasound parameters, peri-operative hemodynamic status and the risk of postoperative delirium.
次要结局
- Carotid artery plaque burden(Before anesthesia (pre-operative))
- Corrected flow time of the common carotid artery (FTc)(Before anesthesia (pre-operative))
- Mean optic nerve sheath diameter (ONSD)(Before anesthesia (pre-operative))
- Intraoperative hypotension episodes(During surgery and anesthesia)
- Intraoperative hypoxia episodes(During surgery and anesthesia)
- Maximum postoperative pain score within 24 hours(Within 24 hours after surgery)
- Incidence of postoperative pneumonia(Perioperative/Periprocedural")
- Postoperative length of hospital stay(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)