Paediatric Early Warning System - A Danish Multi-center Study

NCT02433327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2018-07-02

No results posted yet for this study

Summary

Critical illness in the patient and death can potentially be predicted and prevented. Deterioration of the clinical condition of hospitalised patients is often preceded by physiological changes up to 24 hours before death. Despite this several reports show that lack of identification and proper actions in patients developing acute and critical illness remains a problem.

The purpose of this study is to investigate if Paediatric early Warning Score (PEWS) optimises identification of acute and critically ill children and prevents life-threatening situations. The hypothesis is that implementation of PEWS supported by directions for action algorithms for intervention will have an impact on number of unplanned transfers to intensive care in already hospitalised children.

This study is a multi-centre randomised controlled intervention study designed within a Complex Intervention framework; the study sheds light on the problem, validation of the data collection instrument, testing of the intervention and evaluation. The study involves all paediatric departments and some acute departments in Central Denmark Region. The study is designed as a randomised controlled intervention study where children are randomised to one of two different Paediatric Early Waning Score models.

Development and implementation of PEWS is expected to contribute to reduce the number of children developing acute critical illness, number of admissions to intensive care. PEWS is also expected to contribute to increase professional skills and competences in health professionals. It is expected that this study will contribute towards working with a joint PEWS model in Denmark. Last but not least it must be expected that a PEWS model will contribute to reducing the costs for society as an intensive care hospital bed is more expensive than a hospital bed at a general paediatric department.

Conditions

  • Paediatric Early Warning System

Interventions

OTHER

PEWS - trigger tool

PEWS - trigger tool A PEWS tool is a simple physiological scoring system that can be calculated at the patient's bedside, using parameters, which can easily be measured. Both PEWS tool consist of 7 parameters to be measured, and each individual measuring result would provide the patient with a score from 0-4. The 7 scores should then be added together giving the total PEWS. The children included into the study will be monitored using one of the two different PEWS models. Both model includes measuring vital signs with different intervals according to the child's conditions. Underlying both PEWS tool are algorithms of action for intervention in the critically ill child, interprofessional guidelines and guidance for standardised monitoring.

OTHER

RM - trigger tool

RM - trigger tool A PEWS tool is a simple physiological scoring system that can be calculated at the patient's bedside, using parameters, which can easily be measured. Both PEWS tool consist of 7 parameters to be measured, and each individual measuring result would provide the patient with a score from 0-4. The 7 scores should then be added together giving the total PEWS. The children included into the study will be monitored using one of the two different PEWS models. Both model includes measuring vital signs with different intervals according to the child's conditions. Underlying both PEWS tool are algorithms of action for intervention in the critically ill child, interprofessional guidelines and guidance for standardised monitoring.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Claus S Jensen, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-04-30
Completion
2018-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433327 on ClinicalTrials.gov