Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094404
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
E.P. de Groot, Isala

Tracking Information
First Submitted Date March 8, 2014
First Posted Date March 21, 2014
Last Update Posted Date May 29, 2015
Study Start Date December 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2014)
Reference standard [ Time Frame: <1day ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 20, 2014)
Hospital admission [ Time Frame: <12 hours ]
Hospital or intensive care admission directly following visiting the ED or to the utmost <12h. Admission: yes/no.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 20, 2014)
Expert opinion [ Time Frame: <10 minutes ]
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?
Official Title Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?
Brief 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.

Detailed 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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population - All children presenting at the emergency department of the Isala, Zwolle.
Condition Triage of Children
Intervention Not Provided
Study Groups/Cohorts Children at the ED<18yr
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2015)
727
Original Estimated Enrollment
 (submitted: March 20, 2014)
360
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02094404
Other Study ID Numbers KSEH13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party E.P. de Groot, Isala
Study Sponsor E.P. de Groot
Collaborators Not Provided
Investigators
Principal Investigator: E.P de Groot, MD Isala
PRS Account Isala
Verification Date May 2015