Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults
试验速览
- 阶段
- 不适用
- 发起方
- Ambu A/S
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.
研究概览
简要总结
The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhino laryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally form the ENT department e.g. in the emergency department (ED), intensive care unit (ICU), ward etc., i.e. consults.
详细描述
The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhinolaryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally from the ENT department e.g. in the emergency department, intensive care unit, ward etc., i.e. consults.
The study will be prospective and randomised until 13 procedures have been performed in each group followed by an assessment of the organisational impact and cost comparison of the two technologies. The investigator will track the time and evaluate the device after each procedure. The organisational impact will be accessed by a questionnaire following the study period. A cost comparison will be enabled via tracking all the processes associated with the rhinolaryngoscopes. After tracking all equipment, time, and utilities will be ascribed a cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigator has been trained and conducted at least 5 successful training procedures with both the aScope 4 RhinoLaryngo and the reusable rhinolaryngoscope systems.
- •The investigator on call for consults must be available to fill out the CRF immediately before and after the procedure.
- •The investigator must be dedicated to the study while on call for consults
- •Clinical indication and eligible for a rhino laryngoscopy, as judged by the physician
- •Patients ≥18 years
排除标准
- •If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.
结局指标
主要结局
Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.
时间窗: Prior to procedure
The time (minutes) from indication of the need for a rhinolaryngoscopy, as registered by the physician until initiation of rhinolaryngoscopy. The mean time registered for the experimental arm will be compared to the active comparator arm to assess differences.
次要结局
- Organisational impact- User preference for type of rhinolaryngoscope based on training requirements and skills.(Up to 26 weeks after study completion)
- Availability assessed as the time from indication of the need of the rhinolaryngoscopy until the physician leaves to conduct the rhinolaryngoscopy.(Prior to procedure)
- Organisational impact - User preference for type of rhinolaryngoscope based on working conditions and safety.(Up to 26 weeks after study completion)
- Organisational impact - User preference for type of rhinolaryngoscope assessment of work process.(Up to 26 weeks after study completion)
- Organisational impact - User preference for type of rhinolaryngoscope for workflow.(Up to 26 weeks after study completion)
- Organisational impact - User evaluation for type of rhinolaryngoscope based on time until start of rhinolaryngoscopy.(Up to 26 weeks after study completion)
- Organisational impact - User preference for type of rhinolaryngoscope based on vigilance and monitoring methods.(Up to 26 weeks after study completion)
- Organisational impact - Hospital management preference for type of rhinolaryngoscope based on budget allocation.(Up to 26 weeks after study completion)
- Organisational impact - User preference for type of rhinolaryngoscope based on logistics.(Up to 26 weeks after study completion)
- Intended device(During procedure)
- Rate of complications(During procedure)
- Time from indication for the need of rhinolaryngoscopy until the procedure is completed.(Within 24 hours after completion of procedure.)
- Frequency of procedures(Assessed no more than 48 hours after completed week.)
- Organisational impact - User preference for type of rhinolaryngoscope based on patient/carer involvement in procedure.(Up to 26 weeks after study completion)
- Organisational impact - User preference for type of rhinolaryngoscope based on modes of operation(Up to 26 weeks after study completion)
- Perception of device(During procedure)