Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre: the VISIODYS-PED Randomised Controlled Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 3
- 主要终点
- Proportion of patients inaccurately managed
研究概览
简要总结
Dyspnoea is defined as the sensation of difficult or uncomfortable breathing experienced by a patient. It is a significant concern in emergency care, accounting for 8% of calls to the emergency medical call centre (EMCC) and 10% of Emergency department (ED) admissions. Among paediatric patients, dyspnoea accounts from 14-27% of ED admissions, exhibiting notable seasonal variation. Approximately 10% of these patients require hospitalisation, and 1-3% of cases progress to respiratory failure. All these patients require a comprehensive clinical examination to accurately identify signs of severity, ensuring the timely initiation of specialized and effective treatment.
In France, patients are encouraged to contact the local EMCC before visiting an ED. Medical dispatchers assess the clinical condition by phone, based on medical history, symptoms and current treatment. Based on this assessment, the medical dispatcher determines the appropriate decision which may include providing medical advice, directing the patient to an ED, or deploying a mobile intensive care unit (MICU). Seven percent of calls to an EMCC involve paediatric cases, with nearly half concerning children under six years of age with hyperthermia and dyspnoea as most complaints, particularly during epidemic periods. The medical assessment of paediatric dyspnoea by EMCC is particularly challenging. The inability of children to articulate their symptoms, coupled with parents difficulty in describing the situation - often exacerbated by anxiety - creates significant obstacles. Furthermore, the absence of a direct observation by the physician adds to the complexity and could lead to an inappropriate triage and management.
Telemedicine uses communication technologies for remote consultations, electronic record management, and document sharing. It enables real-time visual evaluation, thereby improving diagnostic accuracy and decision-making. While evidence supports its benefits in managing adult dyspnoeic patients, further research is essential to validate its efficacy in paediatric settings, particularly within EMCC.
This study will aim to evaluate the effectiveness of telemedicine within an EMCC and utilising real-time visualization in reducing inappropriate triage of children requiring care for acute dyspnoea.
详细描述
This is a superiority, prospective, individually randomized, open-label and monocentric study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 3 months to 5 years
- •Call from parent(s) to an EMCC for dyspnea or shortness of breath or difficulty breathing as main complaint
- •Parent or witness with a phone/tablet equipped with a camera
- •Emergency consent or oral consent given by the holder(s) of parental authority to the physician dispatcher
排除标准
- •Child in life-saving emergency
- •Known absence of a telephone network required for the use of video calls
- •Call made by an individual who does not hold parental authority
- •Communication difficulties with the holder(s) of parental authority, not allowing for a clear and fair information
- •Person not benefiting from a social security scheme or through a third party
- •Child who has already participated in the study
研究组 & 干预措施
Standard medical dispatching process (Control group)
The emergency physician dispatcher conducts a standard medical dispatching process.
Addition of telemedicine to standard medical dispatching process (Experimental Group)
The emergency physician dispatcher conducts a standard medical dispatching process with the addition of telemedicine using video calls.
干预措施: Addition of telemedicine to standard medical dispatching process (Experimental Group) (Other)
结局指标
主要结局
Proportion of patients inaccurately managed
时间窗: 24 hours
The primary endpoint is the proportion of patients inaccurately managed (over-triage or under-triage) Over-triage is defined as a situation where a patient is: 1. Directed to an ED following the call, but does not require any specific treatment, diagnostic tests, or hospitalisation, within 24h following the primary call, or 2. Managed by the deployment of a MICU, despite not requiring specific treatment or transfer to an ED, within 24h following the primary call. Under-triage is defined as a situation where a patient is kept at home with medical advice or directed to a family practitioner after the primary call AND later dispatched to hospital by a family practitioner or after a second call to an EMCC for dyspnoea, or hospitalised or dead within 24h following the primary call.
次要结局
- Over-triage(24 hours)
- Under-triage(24 hours)
- Second call to emergency communication center(24 hours)
- Mortality(28 days)
- Hospitalization(28 days)
- Medical decision at the end of the call(At the end of the call to emergency communication center)
- Duration of the call(At the end of the call)
- Proportion of patients in over-triage situation(24 hours)
- Proportion of patients in under-triage situation(24 hours)
- Proportion of patients who called a second time the emergency communication center for dyspnea(24 hours)
- Proportion of deceased patients at day 28(28 days)
- Proportion of patients hospitalized within 28 days(28 days)