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临床试验/NCT05363124
NCT05363124尚未招募不适用

Evaluation of Mobile App to Assist in Pediatric Triage in a Pediatric Emergency Department

Fondation Lenval1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
700
试验地点
1
主要终点
Pediatric Early Warning System calculated by nurse

研究概览

简要总结

Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.

In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs.

In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).

Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in a pediatric emergency department using the mobile application Caducy® (i-Virtual)

详细描述

The number of visits to emergency departments (ED) has been rising steadily for both adult and pediatric patients over the past decades. resulting in an increase in waiting and care times. Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. However, overcrowding in the ED as well as difficulties in monitoring patients waiting for clinical examination, can endanger patient safety. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. An ideal triage system should be able to identify those who require immediate care (high-level emergency) from those who can wait or those who will not require emergency care (intermediate- to low-level emergency). This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.

In France, there is no gold standard in pediatric triage and each hospital uses their own "home-made" triage system. In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs. In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. The PEWS system is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).

Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in our pediatric emergency department using the mobile application Caducy® (i-Virtual).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •patients under 18
  • •visited the PED of Lenval Children's Hospital for medical reason
  • •Parental consent signed

排除标准

  • •Patients visited the PED of Lenval Children's Hospital for a reason other than medical
  • •A sign (s) of vital distress
  • •Patients who were called back,
  • •Patients treated in prehospital care,
  • •Patients who left without an assigned triage level
  • •Non-French speaking parents

研究组 & 干预措施

PEWS calculation

Experimental

PEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure

干预措施: PEWS calculation by parents using AI-based smartphone app (Other)

PEWS calculation

Experimental

PEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure

干预措施: PEWS calculation by nurse using conventional procedure (Other)

结局指标

主要结局

Pediatric Early Warning System calculated by nurse

时间窗: at inclusion

the PEWS score is calculated by nurse using conventional procedure. he Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the score, patients will be classified as follows: * PEWS \[0-2\] = no risk * PEWS\[3-4\] = moderate risk * PEWS \[5-9\] = High risk

Pediatric Early Warning System (PEWS) calculated by parent using smartphone app

时间窗: at inclusion

The Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. the PEWS score is calculated by parent using smartphone app and According to the score, patients will be classified as follows: * PEWS \[0-2\] = no risk * PEWS\[3-4\] = moderate risk * PEWS \[5-9\] = High risk

次要结局

  • PEWS calculated by parents after triage process(until 240 minutes maximum from inclusion)
  • PEWS calculated by nurse after triage process(until 240 minutes maximum from inclusion)
  • Agreement between PEWS and final orientation(through study completion, an average of 6 months)
  • Agreement between PEWS and diagnosis(through study completion, an average of 6 months)
  • Agreement between PEWS and day period(through study completion, an average of 6 months)
  • PEWS calculated by doctor(until 4 hours from inclusion)
  • Agreement between PEWS and group of chief complaint at the triage(through study completion, an average of 6 months)
  • parental satisfaction(at the end of patient participation, an average of 3 hours)
  • Agreement between PEWS and patient age(through study completion, an average of 6 months)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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