In-line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 主要终点
- The aim of the trial is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access in the 48 postoperative hours
研究概览
简要总结
The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access.
In this controlled trial, 268 surgical patients are 1:1 randomised to in-line filtration (study group) and standard care (control group). The incidence of phlebitis (defined as Visual Infusion Phlebitis, VIP score≥2) within 48hrs postoperatively is compared between the two groups, as well as the onset and severity of phlebitis and the reasons for removal of the cannula. The lifespan of venous cannulae and cost-of-care are compared for the study and control groups through a Kaplan-Meier curve. Multivariate Cox regression analysis is performed to evaluate the effect of in-line filtration on risk of phlebitis and cannula removal.
详细描述
A randomised, controlled, clinical trial is performed at the Department of Anesthesia and Intensive Care of the Azienda Ospedaliero-Universitaria Careggi in Florence, Italy, to assess the effects of in-line filtration on the incidence of postoperative phlebitis. The Ethical Committee of the institution has approved the study (CEAV IN17/0000015). Patients preoperatively sign consent forms for participation in this trial.
An incidence of phlebitis equal to 50% within 48 hrs from peripheral venous cannulation has been preliminarily described in our centre during standard care (unpublished data). Two hundred and sixty-eight patients undergoing surgery are 1:1 randomised to in-line filtration (study group) and standard care (control group) to observe a 20% reduction in postoperative phlebitis within 48 hrs after surgery in the study group through a one-side chi-square analysis with statistical power of 90% and statistical significance of 0.025.
Every surgical patient scheduled for surgery, who preoperatively signed the consent form and underwent peripheral venous cannulation, is considered for this study. Patients undergoing central venous catheterisation or long-/middle-term peripheral cannulation are excluded.
On the day of surgery, all enrolled patients undergo standard peripheral venous cannulation according to the up-to-date standard of care. After placement of venous cannula and before the induction of anaesthesia, patients are randomised for in-line filtration or standard care.
For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used during anaesthesia and the following 96 postoperative hours.
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
- Double (Care Provider, Investigator)
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
- •Age>18 years old
- •Consent to trial participation and randomization obtained in preoperative period
排除标准
- •Pregnancy
- •Presence of central vascular access with central or peripheral iserction
- •Presence of long peripheral vascular access such as Midline or MiniMidline
- •Patients envolved in other comparative trial
结局指标
主要结局
The aim of the trial is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access in the 48 postoperative hours
时间窗: VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively
The incidence of phlebitis is evaluated through Visual Infusion Phlebitis (VIP) score.Phlebitis is defined as a VIP score ≥ 2. A Fischer's exact test will be use to evaluate difference between study group and control group.
次要结局
- A secondary objective is to evaluate difference between study group and control group phlebitis onset in the 96 postoperative hours(VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively)
- A secondary objective is to show difference between study group and control group phlebitis severity in the 96 postoperative hours(VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively)
- A secondary objective is to evaluate care cost increase secondary to in-line filtration management between study group and control group(In 96 postoperative hours, all materials used (infusion sets, vascular dressing devices, filters, kit for venipuncture...) to manage vascular access in control group and in study group is registered)
研究者
Gianluca Villa
MD
Careggi Hospital