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临床试验/NCT07739004
NCT07739004招募中不适用

Triage Performance and Physiological Parameters Predicting Serious Illness in Children Presenting With Fever to the Pediatric Emergency Department: A Multicenter Prospective Cohort Study

TC Erciyes University20 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2026年7月28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
入组人数
3,000
试验地点
20
主要终点
Composite serious clinical outcome

研究概览

简要总结

This multicenter prospective observational cohort study evaluates how well the initial triage category assigned by the Turkish Ministry of Health three-level color-coded triage system (Red-Yellow-Green) predicts serious clinical outcomes in children aged 0-18 years who present with fever to pediatric emergency departments. The study additionally assesses whether physiological parameters recorded at triage (heart rate, respiratory rate, oxygen saturation, capillary refill time, AVPU level of consciousness, and general appearance) provide independent and incremental prognostic value beyond the assigned triage category. Ten centers across Turkey will enroll consecutive eligible febrile children over a 3-month period. Routine clinical care and triage decisions are not altered by the study. The primary outcome is a composite serious clinical outcome. The study is reported in accordance with the STROBE and TRIPOD statements.

详细描述

Design: Prospective, multicenter, observational cohort study. Setting: 10 pediatric emergency departments in Turkey; Erciyes University is the coordinating center. Population: consecutive children aged 0-18 years presenting with fever (>=38.0 C at triage or history of fever within the preceding 24 hours). Trauma presentations, elective visits, records with missing triage data, and re-attendances within 72 hours for the same episode are excluded (only the first visit is included). Physiological parameters are recorded on a standardized triage form and are NOT used to change the triage decision. Heart rate is modeled as a continuous variable with age-based z-scores (Fleming reference ranges), with body temperature always included as a covariate to distinguish fever-related from pathological tachycardia. Sample size: assuming a serious-outcome (composite) event rate of ~3%, approximately 3000 children (~90 events) are targeted (~300 per center over 3 months), following Riley et al. (BMJ 2020) criteria (target R2>=0.15, calibration slope>=0.90) in addition to the EPV>=10 rule. A pilot evaluation at the end of the first month recalculates the true event rate. Analysis: Triage performance is summarized with sensitivity, specificity, PPV, NPV, LR+ and LR- with 95% CIs. A pre-specified 3-step mixed-effects logistic regression (centers as random effect) compares Model 1 (triage category only), Model 2 (+ physiological parameters and temperature), and Model 3 (+ laboratory variables in the tested subgroup). Discrimination (ROC/AUC, DeLong test, NRI, IDI) and calibration (calibration curve and slope, O/E ratio) are reported. Missing data are handled by multiple imputation (m=20).

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 0-18 years
  • Presentation to the pediatric emergency department
  • Fever >=38.0 C at triage OR history of fever within the preceding 24 hours

排除标准

  • Presentation due to trauma
  • Elective visits
  • Missing triage data
  • Re-attendance within 72 hours for the same episode (only the first visit is included)

研究组 & 干预措施

Febrile children in the pediatric emergency department

Children aged 0-18 years presenting with fever (>=38.0 C at triage or history of fever within the preceding 24 hours) to a participating pediatric emergency department during the 3-month study period. All undergo routine triage with the Ministry of Health three-level color-coded system; triage decisions and clinical care are not altered by the study.

干预措施: Ministry of Health three-level color-coded triage (Diagnostic Test)

结局指标

主要结局

Composite serious clinical outcome

时间窗: 30 Dys

Presence of at least one of: intensive care unit admission; invasive or non-invasive mechanical ventilation; vasopressor/inotropic therapy; culture- or sterile-body-fluid-confirmed invasive bacterial infection; 30-day mortality.

次要结局

  • Hospital admission with intravenous antibiotics(Up to 30 days)
  • Sepsis protocol activation(Index ED visit (day 1))
  • Intravenous fluid bolus of at least 20 mL/kg(Index ED visit (day 1))
  • Unplanned re-attendance with admission(72 hours)
  • All-cause hospital ward admission(Index ED visit (day 1))
  • Undertriage rate(30 days)
  • Overtriage rate(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yılmaz Seçilmiş

Associate Professor

TC Erciyes University

研究点 (20)

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