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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02094404
Other study ID # KSEH13
Secondary ID
Status Completed
Phase N/A
First received March 8, 2014
Last updated May 28, 2015
Start date December 2013
Est. completion date March 2014

Study information

Verified date May 2015
Source Isala
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

Currently, the Manchester Triage System (MTS) is used to triage all children presenting at the emergency department(ED) in this hospital. This system has been proven safe, but many patients are classified as too urgent. In this hospital adults are prioritised at the ED by a score based on vital signs, the early warning score. A similar score is developed suitable for children. This score, the Pediatric Early Warning Score (PEWS), is already used to determine clinical deterioration.

The investigators hypothesize that children can be triaged safely with the PEWS.

If it is safe, there will be one triage system again at the ED. Another advantage will be more continuity in assessing the condition of patients who are admitted to the hospital.


Description:

Background: Triage systems are used at EDs to prioritize patients to make sure that those who need it, receive immediate care.

The MTS is used for children at EDs by many hospitals worldwide, also at the ED of the Isala, the Netherlands. This triage system has been proven safe, but many patients are classified as too urgent. This is a disadvantage because accurate triage is needed to provide access for immediate ill patients and for sufficient flow at the ED.

Currently, adult patients at the ED of the Isala are classified by the early warning score. This is a score based on vital signs and it is easily calculated. It originally has been developed to determine clinical deterioration. For children normal values are different for each age. Therefore there has been developed the PEWS, which is now only used to evaluate clinical patients. Ideally for the continuity in this hospital, there would be one system which can be used for triage as well as for clinical patients. The investigators hypothesize that the PEWS is a safe alternative for the triage of children at the ED.

Design: A form will be attached on the file of all children presenting at the ED, for recording data. These forms will be collected afterwards. The emergency department nurses will record the vital signs, which the investigators need to calculate the PEWS as well as the urgency determined by the MTS for each patient. The expert opinion will also be recorded. This is de urgency according to the doctor who has seen the patient, maximal acceptable door-to-doctor time: very urgent (immediate), urgent (<15minutes) or normal (<1hour). At the end of the consultation at the ED, the reference standard will be determined for each patient independent of MTS urgency or PEWS, with data available from the patient file. (1) For secondary outcome measures may or may not hospital admission or intensive care admission will be recorded.

No interventions are made and this study is of no influence on the treatment of the patients.


Recruitment information / eligibility

Status Completed
Enrollment 727
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- All children presenting at the Emergency Department of the Isala.

Exclusion Criteria:

- Children seen in room 17, the plaster and little trauma room (because of practical reasons).

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Isala Zwolle Overijssel

Sponsors (1)

Lead Sponsor Collaborator
E.P. de Groot

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Veen M, Steyerberg EW, Ruige M, van Meurs AH, Roukema J, van der Lei J, Moll HA. Manchester triage system in paediatric emergency care: prospective observational study. BMJ. 2008 Sep 22;337:a1501. doi: 10.1136/bmj.a1501. Erratum in: BMJ. 2008;337:a1849. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Expert opinion Assessed directly at the first contact with the patient at the ED by the pediatrician. Maximal acceptable door-to-doctor time: very urgent (immediate), urgent (<15minutes) or normal (<1hour). <10 minutes No
Primary Reference standard A reference standard as developed by van Veen et al with 5 urgency levels to be determined with the information available from the patient file as documented after presentation at the ED.
The reference standard will be separately compared to the MTS as well as the PEWS as determined for each patient presenting at the ED.
<1day No
Secondary Hospital admission Hospital or intensive care admission directly following visiting the ED or to the utmost <12h.
Admission: yes/no.
<12 hours No