Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department (PEDTRIAGE)
2026年8月3日 更新者：Yılmaz Seçilmiş、TC Erciyes University
Triage Performance and Physiological Parameters Predicting Serious Illness in Children Presenting With Fever to the Pediatric Emergency Department: A Multicenter Prospective Cohort Study
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.
研究概览
详细说明
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).
研究类型
观察性的
注册 (估计的)
3000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yilmaz Secilmis, MD
- 电话号码：+905063013174
- 邮箱：yilmazsecilmis@erciyes.edu.tr
学习地点
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Adana、土耳其（türkiye）
- 招聘中
- Adana City Training and Research Hospital
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接触：
- Saadetnur Bozgeyik Aksoy, MD
- 电话号码：+90 05077185767
- 邮箱：saadetnb@gmail.com
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Adana、土耳其（türkiye）
- 招聘中
- Cukurova University Faculty of Medicine
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接触：
- Sevcan Bilen, MD
- 电话号码：+90 532 276 50 84
- 邮箱：svcnbln@hotmail.com
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Antalya、土耳其（türkiye）
- 招聘中
- Akdeniz University Faculty of Medicine
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接触：
- Ozlem Tolu Kendir, MD
- 电话号码：+90 505 304 98 09
- 邮箱：otolu80@yahoo.com
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Eskişehir、土耳其（türkiye）
- 招聘中
- Osmangazi University Faculty of Medicine
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接触：
- Emre Gungor, MD
- 电话号码：+90 506 425 52 40
- 邮箱：emregungormd@gmail.com
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Istanbul、土耳其（türkiye）
- 招聘中
- Kartal Dr. Lutfi Kirdar City Hospital
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接触：
- Feyza Esen
- 电话号码：+90 505 724 32 56
- 邮箱：feyzahusrevoglu@hotmail.com
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Izmir、土耳其（türkiye）
- 招聘中
- Dokuz Eylul University Faculty of Medicine
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接触：
- Emel Ulusoy
- 电话号码：+90 506 914 00 08
- 邮箱：ulusoy.emel@deu.edu.tr
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Kayseri、土耳其（türkiye）
- 招聘中
- Kayseri City Hospital
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接触：
- Murat Dogan, MD
- 电话号码：+905059025999
- 邮箱：doktormurat033@hotmail.com
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Manisa、土耳其（türkiye）
- 招聘中
- Celal Bayar University Faculty of Medicine
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接触：
- Alkan Bal, MD
- 电话号码：+90 505 815 01 33
- 邮箱：balalkan@hotmail.com
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Tokat Province、土耳其（türkiye）
- 招聘中
- Tokat University Faculty of Medicine
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接触：
- Seda Gumustekin Bilgin
- 电话号码：+90 554 206 60 04
- 邮箱：dr.seda.cocukacil@gmail.com
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Talas
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Kayseri、Talas、土耳其（türkiye）、38039
- 招聘中
- Erciyes University Faculty of Medicine
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接触：
- Yilmaz Secilmis, MD
- 电话号码：+905063013174
- 邮箱：yilmazsecilmis@erciyes.edu.tr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Presentation due to trauma
- Elective visits
- Missing triage data
- Re-attendance within 72 hours for the same episode (only the first visit is included)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
At presentation, each child is assigned a triage category (Red, Yellow, or Green) by the triage nurse using the Turkish Ministry of Health three-level color-coded system, and physiological parameters (heart rate, respiratory rate, oxygen saturation, capillary refill time, AVPU level of consciousness, and general appearance) are recorded on a standardized triage form.
This reflects routine care and is not modified for the study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite serious clinical outcome
大体时间：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.
|
30 Dys
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hospital admission with intravenous antibiotics
大体时间：Up to 30 days
|
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
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Up to 30 days
|
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Sepsis protocol activation
大体时间：Index ED visit (day 1)
|
Activation of an institutional sepsis protocol during the index emergency department visit.
|
Index ED visit (day 1)
|
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Intravenous fluid bolus of at least 20 mL/kg
大体时间：Index ED visit (day 1)
|
Administration of an intravenous fluid bolus of at least 20 mL/kg during the index emergency department visit.
|
Index ED visit (day 1)
|
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Unplanned re-attendance with admission
大体时间：72 hours
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Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
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72 hours
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All-cause hospital ward admission
大体时间：Index ED visit (day 1)
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Admission to a hospital ward for any cause.
|
Index ED visit (day 1)
|
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Undertriage rate
大体时间：30 days
|
Proportion of Green-triaged patients who develop the primary composite outcome.
|
30 days
|
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Overtriage rate
大体时间：30 days
|
Proportion of Red-triaged patients who do not develop the primary composite outcome.
|
30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Yilmaz Secilmis、TC Erciyes University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
- Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
- Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
- Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015 Jan 6;162(1):55-63. doi: 10.7326/M14-0697.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月28日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年7月27日
首先提交符合 QC 标准的
2026年7月27日
首次发布 (实际的)
2026年7月31日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- ERU-PEDTRIAGE-2026
- 2026/382 (其他标识符：Erciyes University Clinical Research Ethics Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared publicly.
De-identified data may be made available from the coordinating center on reasonable request, subject to approval by the coordinating ethics committee and a data-sharing agreement, in accordance with institutional and national data-protection regulations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.