Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department (PEDTRIAGE)
3 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Beräknad)
3000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yilmaz Secilmis, MD
- Telefonnummer: +905063013174
- E-post: yilmazsecilmis@erciyes.edu.tr
Studieorter
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Adana, Turkiet (Türkiye)
- Rekrytering
- Adana City Training and Research Hospital
-
Kontakt:
- Saadetnur Bozgeyik Aksoy, MD
- Telefonnummer: +90 05077185767
- E-post: saadetnb@gmail.com
-
Adana, Turkiet (Türkiye)
- Rekrytering
- Cukurova University Faculty of Medicine
-
Kontakt:
- Sevcan Bilen, MD
- Telefonnummer: +90 532 276 50 84
- E-post: svcnbln@hotmail.com
-
Antalya, Turkiet (Türkiye)
- Rekrytering
- Akdeniz University Faculty of Medicine
-
Kontakt:
- Ozlem Tolu Kendir, MD
- Telefonnummer: +90 505 304 98 09
- E-post: otolu80@yahoo.com
-
Eskişehir, Turkiet (Türkiye)
- Rekrytering
- Osmangazi University Faculty of Medicine
-
Kontakt:
- Emre Gungor, MD
- Telefonnummer: +90 506 425 52 40
- E-post: emregungormd@gmail.com
-
Istanbul, Turkiet (Türkiye)
- Rekrytering
- Kartal Dr. Lutfi Kirdar City Hospital
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Kontakt:
- Feyza Esen
- Telefonnummer: +90 505 724 32 56
- E-post: feyzahusrevoglu@hotmail.com
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Izmir, Turkiet (Türkiye)
- Rekrytering
- Dokuz Eylul University Faculty of Medicine
-
Kontakt:
- Emel Ulusoy
- Telefonnummer: +90 506 914 00 08
- E-post: ulusoy.emel@deu.edu.tr
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Kayseri, Turkiet (Türkiye)
- Rekrytering
- Kayseri City Hospital
-
Kontakt:
- Murat Dogan, MD
- Telefonnummer: +905059025999
- E-post: doktormurat033@hotmail.com
-
Manisa, Turkiet (Türkiye)
- Rekrytering
- Celal Bayar University Faculty of Medicine
-
Kontakt:
- Alkan Bal, MD
- Telefonnummer: +90 505 815 01 33
- E-post: balalkan@hotmail.com
-
Tokat Province, Turkiet (Türkiye)
- Rekrytering
- Tokat University Faculty of Medicine
-
Kontakt:
- Seda Gumustekin Bilgin
- Telefonnummer: +90 554 206 60 04
- E-post: dr.seda.cocukacil@gmail.com
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-
Talas
-
Kayseri, Talas, Turkiet (Türkiye), 38039
- Rekrytering
- Erciyes University Faculty of Medicine
-
Kontakt:
- Yilmaz Secilmis, MD
- Telefonnummer: +905063013174
- E-post: yilmazsecilmis@erciyes.edu.tr
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite serious clinical outcome
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hospital admission with intravenous antibiotics
Tidsram: Up to 30 days
|
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
|
Up to 30 days
|
|
Sepsis protocol activation
Tidsram: Index ED visit (day 1)
|
Activation of an institutional sepsis protocol during the index emergency department visit.
|
Index ED visit (day 1)
|
|
Intravenous fluid bolus of at least 20 mL/kg
Tidsram: 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)
|
|
Unplanned re-attendance with admission
Tidsram: 72 hours
|
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
|
72 hours
|
|
All-cause hospital ward admission
Tidsram: Index ED visit (day 1)
|
Admission to a hospital ward for any cause.
|
Index ED visit (day 1)
|
|
Undertriage rate
Tidsram: 30 days
|
Proportion of Green-triaged patients who develop the primary composite outcome.
|
30 days
|
|
Overtriage rate
Tidsram: 30 days
|
Proportion of Red-triaged patients who do not develop the primary composite outcome.
|
30 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Yilmaz Secilmis, TC Erciyes University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 juli 2026
Primärt slutförande (Beräknad)
1 november 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
27 juli 2026
Först inskickad som uppfyllde QC-kriterierna
27 juli 2026
Första postat (Faktisk)
31 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ERU-PEDTRIAGE-2026
- 2026/382 (Annan identifierare: Erciyes University Clinical Research Ethics Committee)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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Nej
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