Triage of ChildrenNCT02094404
Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?
An observational study of Triage of Children, run by E.P. de Groot at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Triage of Children
- How many people
- 727 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: - All children presenting at the emergency department of the Isala, Zwolle.
Who may be able to join
- All children presenting at the Emergency Department of the Isala.
Who cannot join
- Children seen in room 17, the plaster and little trauma room (because of practical reasons).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Triage of Children
- Keywords
- Emergency Department, Pediatric Early Warning Score, Manchester Triage System
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children at the ED<18yr | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: <1day
Secondary outcomes (1)
Hospital admission
Hospital or intensive care admission directly following visiting the ED or to the utmost <12h.
Admission: yes/no.
Measured: <12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triage of ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- E.P. de Groot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, E.P. de Groot, Isala
- Investigators
- E.P de Groot, MD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094404
- Sponsor's protocol ID
- KSEH13
- Status last verified
- May 2015
- First submitted
- 8 Mar 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18809587
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?
- ClinicalTrials.gov ID
- NCT02094404
- Acronym / sponsor ID
- KSEH13
- Conditions
- Triage of Children
- Keywords
- Emergency Department, Pediatric Early Warning Score, Manchester Triage System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- E.P. de GrootUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children at the ED<18yr | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- - All children presenting at the emergency department of the Isala, Zwolle.
Key inclusion criteria (1 listed)
- All children presenting at the Emergency Department of the Isala.
Key exclusion criteria (1 listed)
- Children seen in room 17, the plaster and little trauma room (because of practical reasons).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Hospital admission
Time frame: <12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Background: PubMed 18809587van 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.
Related trials for Triage of Children
RecruitingObservational study
Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department
Fever, Triage
Recruiting
A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
Infectious Disease, Febrile Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.P de Groot, MD principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triage of Children, run by E.P. de Groot at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference standard (time frame: <1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.