Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 2
- 主要终点
- PIVC failure before the intended intravenous treatment course is complete.
研究概览
简要总结
Intravenous (IV) catheter placement is the most common medical procedure in emergency department settings. IVs are used to deliver medications, fluids and blood products to patients. At the Children's Hospital of Eastern Ontario, approximately three-quarters of children admitted to hospital have an IV inserted while they are in the emergency department. However, a challenge associated with IVs is that they sometimes stop working or fall out before treatment has been completed (this is known as IV failure). When IVs fail, a new IV often needs to be placed. Children rank IV placement as one of the leading causes of pain in the hospital setting. The investigators are interested in understanding whether there are strategies that can help keep IVs in place longer for children admitted to hospital.
Previous studies investigating whether certain types of bandages over IV sites are helpful in keeping IVs in longer found all bandages performed about the same. However, a recent study of adult patients showed that using medical-grade skin glue to secure the IV significantly reduced IV failure rates when compared to usual care. There have been no similar studies in children. The objective of this study is to understand whether placement of skin glue at IV insertion sites is effective in decreasing IV failure rates in children. This study will take place in the emergency department at Children's Hospital of Eastern Ontario (CHEO). Consenting children will be randomly assigned to receive IV placement either with or without skin glue (one drop at the IV insertion site and another drop under the hub of the catheter), along with otherwise standard securement with a transparent dressing. The investigators will look at the numbers of children in each group whose IVs fail before their intended treatment course is complete. This study has the potential to improve patient and family satisfaction, decrease nursing workload and reduce healthcare costs.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0 days to 18 years
- •Patient must require a PIVC as part of their management plan
- •Patient must be physically in the ED at the time of PIVC insertion
排除标准
- •At the time of insertion, the treating physician anticipates the patient will likely be discharged from the ED (with or without the PIVC in place)
- •Known allergy to skin glue, glue removal wipe, or standard catheter securement materials
- •Active infection at site of PIVC insertion
- •Insurmountable language barrier (patient's parent/guardian is unable to understand English or French well enough to give informed consent and participate in follow-up)
- •Previous enrolment in the trial
- •PIVC is expected to be used for chemotherapy (note: these are changed every 4 days even with good blood return)
- •Life-threatening or critical presentation in which consent is unable to be obtained
结局指标
主要结局
PIVC failure before the intended intravenous treatment course is complete.
时间窗: Measured at the point at which the PIVC fails, up to 14 days
PIVC failure is defined by a composite of dislodgement, occlusion, signs of infection, and phlebitis. Dislodgement is defined as subcutaneous extravasation, accidental removal by patient or staff, or history that the PIVC "fell out". Occlusion is defined as an inability to flush the catheter with 2-3ccs of normal saline or history that the PIVC was "not working". Infection is defined as presence of pus, erythema, pain, and/or swelling around the PIVC site in keeping with a clinical suspicion of infection or cellulitis. Phlebitis is defined as a painful, palpable, cord-like vein.If the PIVC fails (as per the above definition) before an order is written to discontinue the PIVC, it will be determined the device failed before the treatment course was complete.
次要结局
- Time to PIVC failure(Time from PIVC insertion to either a) PIVC failure or b) when PIVC is not longer needed for treatment, up to 14 days)
- PIVC failure or removal as a result of each of the following: a) dislodgement, b) occlusion, c) infection, and d) phlebitis(End of study period, up to 14 days)
- Pain on PIVC removal as experienced by the patient or observed by the caregiver(Measured at the time of PIVC removal, up to 14 days)
- Difficulty of PIVC removal(Measured at the time of PIVC removal, up to 14 days)
研究者
Maala Bhatt
Pediatric Emergency Medicine Staff Physician
Children's Hospital of Eastern Ontario