A Prospective Observational Study Of Early Warning Score Combined With Bedside Assessments In Accelerating Emergency Care Initiation And Improving Patient Prognosis In The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- ICU-Level Organ Support or In-Hospital Mortality Within 24 Hours
研究概览
简要总结
Brief Summary This study, sponsored by the National Natural Science Foundation of China and conducted at the Emergency Department (ED) of Jiangnan University Affiliated Hospital, aims to optimize emergency care for critically ill patients via combining "early warning scoring" and "bedside rapid assessment".
Why the Study? Delayed identification of emergency patients at high risk of deterioration worsens outcomes; traditional assessments often miss subtle deterioration signs. This study seeks a more efficient assessment approach to help clinicians recognize high-risk patients earlier and start targeted treatment faster.
Eligibility 200-300 participants will be recruited from the hospital's ED for acute diseases (e.g., severe infection, heart failure, trauma). Inclusion: aged 18-80, with informed consent (or family consent if unable to communicate). Exclusion: severe mental illness, non-intervenable terminal illness.
Study Process All participants receive routine emergency care. The research team uses a new combined assessment tool: first a 2-minute bedside rapid assessment (vital signs, consciousness, breathing), then early warning scoring to classify risk. Doctors adjust treatment priority based on results. The team records time from admission to treatment initiation and 72-hour condition changes. No additional invasive procedures/experimental drugs are used, and no extra cost for assessments.
Potential Benefits Participants may get more timely, targeted emergency care (reducing deterioration risk and hospital stay). Study results will improve emergency care at this and other hospitals, benefiting more emergency patients.
Study Leadership Principal Investigator: Dr. Jun Liu (Attending Physician, ED of Jiangnan University Affiliated Hospital) Responsible Party: Jiangnan University Affiliated Hospital (Sponsor) Ethical Approval: Approved by the hospital's Medical Ethics Committee (Approval No.: To be filled with actual number)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for enrollment if they meet all of the following conditions:
- •Age between 18 and 80 years at the time of presentation.
- •Presentation to the emergency department (ED) for acute medical evaluation.
- •Completion of at least one documented Early Warning Score (EWS) assessment upon ED admission or during the ED stay.
排除标准
- •Patients will be excluded if they meet any of the following criteria:
- •Do-not-resuscitate (DNR) orders or enrollment in a palliative/comfort care pathway at the time of presentation.
- •Cardiac arrest upon arrival to the ED (unresponsive, pulseless, requiring resuscitation without return of spontaneous circulation).
- •Transfer out of the hospital (to another institution or to the operating room for immediate surgery) within 24 hours of ED admission.
- •History of major cardiac surgery (e.g., coronary artery bypass grafting, valve replacement) or heart transplantation, as these conditions may alter baseline hemodynamics and limit EWS applicability.
- •Severe chronic organ dysfunction, including:
- •End-stage renal disease requiring maintenance dialysis; Severe hepatic insufficiency (Child-Pugh class C or equivalent); Advanced heart failure (New York Heart Association class IV).
- •Known allergy or contraindication to iodinated contrast media (if relevant laboratory or imaging assessments are required for outcome evaluation).
- •Pregnancy, due to altered physiological parameters and ethical considerations.
- •Incomplete or missing clinical records, preventing calculation of EWS or confirmation of study endpoints.
- •Duplicate enrollment due to repeated ED visits or readmissions during the study period (only the first eligible admission will be included).
研究组 & 干预措施
Optimized ED Bedside Nursing Protocol
Arm 1 (Intervention: Optimized ED Assessment) 12 clusters (3 hospitals × 6 depts, day/night shifts) randomized to intervention in 10 phases. Participants get "mNEWS + structured bedside rapid assessment" at triage: 3-min standard assessment (2-min checks: BP, HR, RR, SpO₂, GCS, respiratory status; 1-min mNEWS for risk stratification). Staff prioritize treatment via results. Optimized protocol replaces conventional post-randomization.
干预措施: Optimized ED Bedside Nursing Protocol (Procedure)
Control Arm: Conventional Emergency Assessment
Control: Conventional ED Assessment Waitlist clusters keep routine assessment pre-randomization. Conventional process: vital sign recording (BP, HR, RR) + subjective severity judgment, no structured scoring/risk stratification. Clusters switch to optimized post-wait, but control data collected only during conventional implementation.
结局指标
主要结局
ICU-Level Organ Support or In-Hospital Mortality Within 24 Hours
时间窗: From the time of patient admission (admission time) up to 24 hours after admission time.
Composite endpoint defined as the occurrence of either "ICU-level organ support" or "in-hospital mortality" within 24 hours after EWS score ≥5 (T0). "ICU-level organ support" includes: invasive mechanical ventilation initiation, continuous vasopressor use for ≥30 minutes, or CRRT activation. "In-hospital mortality" refers to death occurring during the current hospitalization. Data are extracted from electronic medical records (EMR) and ICU information systems, with event time confirmed by the earliest timestamp of organ support initiation or death notification.
次要结局
- T3 Compliance Rate(Within the first 24 hours from ED registration)
- Door-to-Key Intervention Time(Within the first 24 hours from ED registration)
- Incidence of Over-Escalation and Delayed Escalation(From T0 (initial escalation decision) until confirmation of intervention necessity or time limit deviation, whichever occurs first, assessed up to 72 hours post-T0.)
- 72-Hour ICU Admission Rate(From T0 (time of enrollment or index event) until ICU admission or hospital discharge, whichever occurs first, assessed up to 72 hours post-T0.)
- 28-Day In-Hospital Mortality(From patient ED registration up to 28 days after registration)
研究者
Jun Liu
Attending Physician
Affiliated Hospital of Jiangnan University