Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges

University of Iowa0 个研究点目标入组 27,637 人开始时间: 2016年8月最近更新: 2017年11月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Iowa
入组人数: 27,637
主要终点: Cost of using radiography to rule out the presence of a retained sponge

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently reported serious adverse event for five of the last six years. Retained surgical sponges have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection, fistulas/ bowel obstructions, and death). The national standard for prevention of retained surgical sponges relies heavily on manual counting several times before, during, and after the surgical procedure. If a sponge is missing, a series of steps are taken to reconcile the count. These steps require extra time and pull personnel away from other competing priorities. If the final closing count remains incorrect, it is common practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is expensive and increases the time required for the surgery.

Novel technology using a radiofrequency (RF) is now available for detecting and preventing retained surgical sponges. The objective of this study is to evaluate the in-use effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost of searching for sponges and prevention of incorrect counts.

详细描述

Background:

Retained surgical items (e.g. sponges, needles, and instruments) remain one of the sentinel events most frequently reported to The Joint Commission, and are estimated to occur in 1: 5500 surgeries. These serious adverse events have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection or sepsis, fistulas/ bowel obstructions, visceral perforation, and death). Cotton gauze sponges account for 48-69% of retained surgical items, and result in more serious tissue reaction than metal items. The national standard for prevention of retained surgical sponges relies heavily on manual counting, a process that occurs prior to incision, at the time of closing a cavity within a cavity, closing the first layer of tissue, and closing skin. The immediate outcome of the closing counts is either correct or unresolved. If unresolved, a series of steps are taken to reconcile the count (surgeon notified, wound searched, sterile field searched, room searched, count repeated). These steps require extra time and effort, pulling personnel away from other competing priorities. If the final closing count remains incorrect, it is common practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge. The practice of searching for misplaced sponges and using radiography to rule out the presence of a retained sponge extend the operating time and add to costs associated care of the patient in surgery. Novel technology is now available for detecting and preventing retained surgical sponges. The technology uses a radiofrequency (RF) chip in the sponge, and a mat or wand that scans the patient for a sponge. Only one clinical trial has evaluated the in-use effectiveness of this RF technology. No retained sponges occurred during the 18 month trial. However the sample size was not large enough to determine significance.

Primary Objective:

The objective in this Health Services Research is to evaluate the in-use effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost of searching for sponges and prevention of incorrect counts.

Specific Aims are:

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 是

入选标准

•We estimate including 27,000 patients during the total of 18 months.
•The first part of the sample will be retrospective, all patients undergoing surgery in the Main Operating Room during a 9 month period of time of the RF sponge detection system (February through October, 2014) This time frame was selected to allow inclusion of data from our previous study.
•The second part of the sample will be prospective, for nine months after implementation of the RF sponge detection system.

排除标准

•ophthalmology, dentistry, non-surgical procedures, aborted surgical procedures, surgeries during which the patient expired, and surgeries performed outside of the Main Operating Room.