The Bar Coded Sponge Study

NCT ID: NCT00282750

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-08-31

Brief Summary

The purpose of this study is to test whether bar coded surgical sponges can significantly increase the safety of operations, specifically by (1) reducing discrepancies and miscounts, (2) reducing total staff time spent on sponge counting, and (3) reducing disruptions to the operating room as a system. Also, the study aims to further characterize the limitations of the current surgical sponge counting protocol.

Detailed Description

Prior work by Dr. Gawande showed that the incidence of a retained foreign body is between 1 in 9000 and 1 in 19000 inpatient operations, or at least once a year for a hospital of any size. Leaving foreign objects in body cavities after surgery can lead to infection, bowel obstruction and in some cases, death. The current approach to preventing this problem is based on adherence to a counting protocol to check the number of instruments and sponges at the beginning and end of the case. The problem of retained foreign body is often attributed to error in the counting process-for example in the case of a retained object, count totals at the beginning and end of the case can be erroneous if an item was not initially counted, or if an item was "double- counted" at the end of a case. In addition to this potential for incorrect counts, the counting protocols can lead to disruptions in case flow and inefficiencies.

In an observational study of surgical performance, which brought human factors experts into Brigham and Women's Hospital operating rooms to examine 10 complex cases, counting protocols for tracking instruments and sponges in particular played a surprisingly negative role on team performance. After the incision was made, nurses devoted an average of 35 minutes to the counting protocols. This represented 14.5% of the operative time. During this time, the investigators were able to document substantial negative effects on surgical work while the nurses were involved in the counting protocol. Furthermore, a counting discrepancy was observed to occur in two-thirds of the cases with a total of 17 discrepancies in 9 cases. As a result, in several patients, progress of a still-incomplete operation had to be substantially delayed or suspended while the nurses attempted to reconcile inconsistencies.

Based on these 2 studies, we conducted a rigorous search and innovation process, generating five possible technologies to detect when instruments or sponges are left behind. Discussions with engineers and a focus group of operating room nurses identified two of these technologies as most feasible for adoption: (1) bar-coded sponges; and (2) a computer vision system for tracking instruments.

SurgiCount Medical, which has subsequently joined Patient Safety Technologies, both of Los Angeles, has designed the Safety-sponge System, which utilizes bar-coded sponges and is now available for testing. The 4" x 4" X-ray detectable gauze sponges and 18" x 18" X-Ray detectable laparotomy pads are manufactured in the same fashion as sponges currently used today. They contain the X-ray detectable strip that can identify a retained sponge on a plain X-ray. A unique bar code (data matrix code) has been securely affixed to each sponge. The datamatrix code with ECC200 error correction allows for accuracy up to 1 error in 10.5 million (worst case), 1 in 612.9 million (best case). FDA 510K exemption status for the bar coded sponge has already been secured by the manufacturer. The bar code detector (sponge counter) has been designed as a small handheld computer with a touchscreen display.

Before introducing new technology into a healthcare system, it is important to study the effect that technology will have on the system. This includes both whether the new technology has the desired effect, but also whether there are any unintended negative effects. Our pre-clinical simulations suggest that the Safety-Sponge System has the potential to improve safety and efficiency in the operating room and other hospitals are moving ahead with purchase of the system. However we argue that the benefit must be proven in a randomized trial comparing it to the traditional counting protocol.

If our hypothesis is correct, this technology could revolutionize the counting procedures and improve both safety and efficiency in the operating room. This could decrease the risk of retained foreign bodies for patients. In addition, it could decrease the workload for the nursing staff in the operating room, leading to improvements in their working conditions and the overall safety of the system.

Comparisons: patients will be randomized to one of two equal groups: usual counting protocol versus bar-code technology assisted counting.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Bar coded sponge and scanner

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing a scheduled general surgery (or subspecialty of general surgery) procedure in the general surgery operating room of the Brigham and Women's Hospital in Boston, MA, during the study period are eligible for enrollment in the study.
• Start times for eligible cases must be between 7AM and 3PM on a weekday.

Exclusion Criteria

• Patients in the pre-op area who have already received pre-op sedation and have not yet been consented
• Patients who are undergoing a procedure by a specialty other than general surgery
• Patients whose procedure is being performed by a team whose members are not all trained to use the Bar Coded Sponge System
• After hours, weekend, add-on, or emergency cases
• Pregnant women
• Patients whose consent needs to be obtained through a surrogate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient Safety Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Atul A Gawande, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003 Jan 16;348(3):229-35. doi: 10.1056/NEJMsa021721.

Reference Type: BACKGROUND

PMID: 12529464 (View on PubMed)

Recommended practices for sponge, sharp, and instrument counts. AORN Recommended Practices Committee. Association of periOperative Registered Nurses. AORN J. 1999 Dec;70(6):1083-9. doi: 10.1016/s0001-2092(06)62224-2. No abstract available.

Reference Type: BACKGROUND

PMID: 10635432 (View on PubMed)

Christian CK, Gustafson ML, Roth EM, Sheridan TB, Gandhi TK, Dwyer K, Zinner MJ, Dierks MM. A prospective study of patient safety in the operating room. Surgery. 2006 Feb;139(2):159-73. doi: 10.1016/j.surg.2005.07.037.

Reference Type: BACKGROUND

PMID: 16455323 (View on PubMed)

Other Identifiers

2005-P-002344

Identifier Type: -

Identifier Source: org_study_id