An open labelled, randomized, controlled clinical trial to study the performance and safety of Intravenous line Organizer in patients admitted to tertiary teaching hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the greater autonomy, mobility and comfort using a global scale (0-4 scale where 0- no mobility and 4- highest mobility) by a physician, nurse and patient or patient care giver
研究概览
简要总结
This is an open labeled, randomized, controlled clinical study to study the performance and safety of Intravenous Line Organizer in patients admitted to tertiary teaching hospital. The objective is to assess the performance and safety of those patients with and without Intravenous line Organizer in patients admitted to medicine and paediatric wards and determine the perception of Physician, Nurses, patients and patients caregiver on effectiveness of the device. Device Usability questionnaire on subject’s perception, patients autonomy, mobility and comfort will be assessed by Global scale, ease of operability scale, Severity of Intravenous Line Entanglement, skin irritation and AE,SAE were assessed.
The assessment will be done during visit 2 (treatment phase) and During visit 3 (end of visit). The result of the study will be summarized with summary statistics including average and standard deviation (SD) for continuous variable and frequency and percentages for categorical variables.
Any AEs will be summarized with a number and the percentage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Emergency rooms for patient hydration line (Glucose), Haematology, Pediatrics up to 18 years, Operations (OR) I.C.U. (Intensive Care Units) From simple to complicated.
排除标准
- •1.Skin allergy 2.Skin burns
- •Pregnant and lactating women
- •Psychiatric illness patients
- •Severe illness patients
- •Not willing to obtain informed consent.
结局指标
主要结局
To assess the greater autonomy, mobility and comfort using a global scale (0-4 scale where 0- no mobility and 4- highest mobility) by a physician, nurse and patient or patient care giver
时间窗: Visit 1 (Baseline) | Visit 2 (During the study) | Visit 3 (End of the study)
次要结局
- To assess the Device Usability questionnaire on subject’s perception by nurse and patient or patient care giver(End of study)
- To assess the skin irritation(Start to End of study)
- .To assess the adverse events(Start to End of study)
- To assess the ease of operability and set up by a physician, nurse and patient or patient care giver (0- Not easy and 4- Very Easy)(Start to end of study)
- To assess the Severity of Intravenous Line(Entanglement by Medical Line Entanglement scale by a physician, nurse and patient or patient care giver)