Surgical Complication Nec Clinical Trial
Official title:
Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges
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.
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:
1. To compare the estimated time and cost of searching for sponges and using radiography to
rule out the presence of retained sponges before and after implementation of a RF sponge
detection system.
2. To compare the incidence of incorrect final closing counts before and after
implementation of a RF sponge detection system.
Study Design:
Using deidentified existing data, investigators propose a quasiexperimental study evaluating
the outcomes of using RF surgical sponge detection system. The setting is the University of
Iowa Hospitals and Clinics, a 711-bed academic medical center, a Level 1 trauma center,
located in Iowa City, Iowa. The University of Iowa Institutional Review Board has determined
that this study does not meet the regulatory definition of human subjects research.
Primary Endpoints
1. The estimated time and cost of searching for sponges and using radiography to rule out
the presence of retained surgical sponges.
2. The frequency of incorrect final closing sponge counts.
Data for individual patients will be recorded by the circulating nurses in a questionnaire
embedded in the surgical log of Epic Systems®, module Optime®. The questionnaire will consist
of three individual counts: initial closing, final closing, and additional count. If the
first question, "was a search required" is answered "yes", four subsequent questions will be
asked: type of sponge, actions taken, number of minutes required, and the location of the
sponge if found. Data will be retrieved from the Health Information System (HIS) using S.A.P.
® Business Objects™ (surgical volume, surgical service) and Crystal reports (details about
searches for sponges). Incorrect final closing counts are documented in the Patient Safety
Net® electronic event reporting system. Data will be retrieved from events reported within
the category of "count incomplete or not done" and "count incorrect". Data will be retrieved
by HIS personnel and provided via a report to the Director of Clinical Functions responsible
for the Main Operating Room. This report is part of the quality improvement program.
Electronic data will be stored in the College of Nursing, the University of Iowa, on the
college's secure server. Data will be cleaned by a data manager and analyzed by the college's
statistician.
Analysis:
Aim 1: Minutes of time spent searching for misplaced sponges will be analyzed using ranges,
means, and standard deviations. Comparison before and after implementation of the RF
detection technology will be described as percentages and analyzed using chi square with
Yates correction. To provide the best estimate of the resources used in searching for
sponges, investigators will use published data on operating room costs per minute to estimate
search costs ($17.23). However, there are significant differences across institutions. To
accommodate this broad range of potential adopters of this RF detection technology and show
differences in potential cost-effectiveness, in addition to using the average estimate of
operating room time cost from the literature, investigators will construct lower bound and
upper bound estimates of the operating room time costs to provide a range of cost estimates
to use in assessing the RF detection technology intervention.
Investigators further adjust search costs for variation in practices during searches. At
times surgeons continue with the procedure (e.g. closing the wound) while in other cases
surgeons will assist with efforts to locate the sponge. As investigators are interested in
time spent on non-productive searches, investigators will use a range of estimates of
non-productive search costs. Investigators start with 100% non-productive and also estimate
based on 75% non-productive (25% of the search time moving forward with the procedure) and
50% non-productive (50% of the search time moving forward with the procedure). Investigators
will use the average radiography costs from published literature ($286) in addition to the
operating room time associated with obtaining an intraoperative radiograph (30minutes). All
times and costs will be analyzed using ranges, means, and standard deviations. Comparison
before and after implementation of the RF detection technology will be described as
percentages and analyzed using chi square with Yates correction.
Aim 2: To compare the incidence of incorrect final closing counts The number of incorrect
final closing counts before and after implementation of a RF sponge detection system will be
analyzed using ranges, means, and standard deviations. Comparison before and after
implementation of the RF detection technology will be described as percentages and analyzed
using chi square with Yates correction.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
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