跳至主要内容
临床试验/NCT05400707
NCT05400707招募中不适用

Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE V-VII)

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 6,467 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,467
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

This study is to evaluate a tool capable of improved risk prediction regarding the 30-day mortality. The primary objective of this study is hospitalization, ICU-admission, morbidity and mortality in correlation with external validation of International Early Warning Score (IEWS) and decision-making processes regarding diagnosis, treatment and disposition in the ED.

详细描述

Most emergency departments (EDs) perform an initial risk stratification of patients, called triage. Triage defines the process of systematically grouping patients according to their treatment priority on the base of algorithms in an environment with scarce health care resources. To this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints. All of these systems have their shortcomings, especially in nonspecific ED presentations and in older patients. The primary objective of this study is hospitalization, ICU-admission, morbidity and mortality in correlation with external validation of International Early Warning Score (IEWS) and decision-making processes regarding diagnosis, treatment and disposition in the ED.

In this national single centre, prospective, consecutive, observational all-comers study patients entering the ED undergo triage and will be verbally informed about the study. First, each patient's vital signs (respiratory rate, oxygen saturation, heart rate, blood pressure, temperature) are measured and pain is rated on a scale of 0 to 10. In addition, the patient's level of consciousness is assessed using the AVPUC scale (alert, new confusion, verbal, pain, unresponsive, new confusion). Patients are asked to rate their own mobility between stable walking without aids or limited mobility with aids (walking aid, wheelchair, lying down). In addition, the patient's mobility is observed by the triage staff. The probability that the patient will be admitted as an inpatient is then assessed. A Clinical Frailty Scale (CFS) is also completed for patients over 65. After triage, patients are transferred to the treatment unit. Patients in need of immediate therapy, such as analgesia, will receive therapy before start of the interview. Patients will then be approached by a member of the study personnel and will be asked "which symptoms are you experiencing at the moment?". The question will be repeated 3 times, Answers will be recorded by ticking boxes in the CRF for a predefined list of 37 symptoms. Then, patients will be asked "which of the symptoms you reported is most important to you?". Patients are asked for their opinion on whether they should be discharged home after emergency treatment or whether they should stay in the hospital. Patients over the age of 65 are asked the following: "generally asked: what matters most to you at the moment?" and "why is that important for you?".

Then, the attending senior physicians are asked how injured/ill they rate the patients on a scale from 0 (not ill/injured) to 10 (very ill/injured). The senior physicians are asked questions about decision-making in the emergency department. With regard to diagnostics, they are asked what type of diagnostic decision is involved (simple or complex decision), whether there was time pressure when making the diagnostic decision and which factors formed the basis for their diagnostic decision (list of 14 factors, numbered according to importance if applicable). Regarding therapy, respondents were also asked what type of therapeutic decision was involved (simple or complex decision), whether there was time pressure in making the therapeutic decision, and which factors formed the basis for their therapeutic decision (list of 14 factors, numbered according to importance if applicable). Then the disposition of the patient (ambulatory or hospitalized) is defined. For ambulant patients, senior physicians are asked which factors formed the basis for their ambulant disposition (list of 9 factors, numbered according to importance if applicable). For hospitalized patients, the senior physicians are asked which factors were the basis for their inpatient disposition (list of 17 factors, numbered according to importance if applicable). Finally, the attending physicians are asked who made the disposition decision.

Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.

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

入选标准

  • Patients presenting to the ED of the University Hospital Basel over a timecourse of 9 weeks in 2022, 2024, 2026

排除标准

  • Obstetric, ophthalmologic, and paediatric patients will not be included
  • unwillingness to participate
  • insufficient ability to communicate with the study personnel.

研究组 & 干预措施

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of vital signs (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of patient mobility at presentation (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of level of consciousness by AVPUC scale (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of symptoms patients presenting when admitted to ED (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of what matters most in patients of 65 years and older (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Assessment of Decision-making in senior physicians (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Pain Numeric Rating Scale (NRS) (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Clinical Frailty Scale (CFS) (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Peripheral Perfusion Index (PPI) (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Capillary Refill Time (CRT) (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Mottling Score (MS) (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Mental health complaints (Diagnostic Test)

patients admitted to emergency ward of the University Hospital Basel.

干预措施: Altered mental status - a vital sign (Diagnostic Test)

结局指标

主要结局

30-day mortality

时间窗: within 30 days of the day of presentation to the ED

30-day mortality is defined as death within 30 days of the day of presentation to the ED

次要结局

  • Number of ICU-admissions(at baseline (= day of presentation to the ED))
  • Number of hospitalizations(at baseline (= day of presentation to the ED))
  • Death rate (In-hospital mortality)(from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED))
  • 100-day mortality(within 100 days of the day of presentation to the ED)
  • Number of institutionalisations(within 100 days of the day of presentation to the ED)
  • Morbidity(within 100 days of the day of presentation to the ED)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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