Paediatric Early Warning System - A Danish Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- Unplanned transfers to intensive care or transfers from regional hospitals to university hospital owing to clinical deterioration
研究概览
简要总结
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.
详细描述
Introduction Evolving critical illness in the patient and death can potentially be predicted and prevented. Observation studies indicate that deterioration of the clinical condition of hospitalised patients is often preceded by physiological changes up to 24 hours before death. Focus in adult patients has for a number of years been on development of risk scoring system, also called "Early Warning Score" (EWS) systematically measuring the patients vital status. International experience shows that systematic observation by EWS accompanied by action algorithms contributes to prevent cardiac arrest, death and transfer to intensive care.
In many areas children are different from adults; there are e.g. physiological and anatomical differences and an EWS system developed for adult can thus not be used in children. Challenges in assessing if a child is critically ill are related to the child's symptoms of serious illness often being uncharacteristic. Children can seem relatively unaffected until a short time before circulatory insufficiency and cardiac arrest.
Thus, there is a need for developing and investigating if an EWS model for ill children has a significant influence on children's development of acute conditions.
Background In Denmark, more than 100,000 children below the age of 15 years are admitted annually. International studies show that 8.5 - 14.0% of cardiac arrest incidences in intensive care units involve paediatric patients. Survival is only between 15 - 33% with subsequent significant neurological outcome in 35% of the surviving children.
The intention with an EWS system for admitted patients is to ensure that staff identifies a deterioration in the patient's condition in time. Each value releases a "score" and the total score determines if treatment should be initiated. International studies in adult patients have shown that up to 24 hours prior to development of cardiac arrest or life-threatening situations show signs of acute critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children admitted to the participating departments
- •All children examined at the acute paediatric assessment unit in Central Denmark Region.
排除标准
- •Children admitted to neonatal wards
- •Children admitted to intensive care units
- •Children dead upon arrival to hospital
- •Children admitted due to social-interaction problems.
结局指标
主要结局
Unplanned transfers to intensive care or transfers from regional hospitals to university hospital owing to clinical deterioration
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Number of unplanned transfers to intensive care in already hospitalised children
次要结局
- Length of hospital stay(through study completion an expected average of 2 years)
- Paediatric index of mortality score 3(through study completion an expected average of 2 years)
- Invasive ventilation(through study completion an expected average of 2 years)
- Use of inotropes(through study completion an expected average of 2 years)
- Length of PICU stay(through study completion an expected average of 2 years)
- Continuous Positive Airway Pressure(through study completion an expected average of 2 years)
- Extra Corporal Membran Oxygenation(through study completion an expected average of 2 years)
研究者
Claus Sixtus Jensen
Clinical Nurse Specialist, PhD student
Aarhus University Hospital