The Bar Coded Sponge Study

NCT00282750 | Completed

• 1 other identifier: 2005-P-002344
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

"Surgery"[MeSH]; "Surgical Sponges"[MeSH]; "Automatic Data Processing"[MeSH]

Outcome Measures

Primary Outcomes (17)

• The amount of time per operating room staff member (circulating nurse and scrub technician) spent on sponge and instrument counts.

• The phase of the counting episode (initial counts, objects added to field, closing counts, or repeat counts).

• The number of and types of sponges added to the table during each counting event. Discrepancies, miscounts in the sponge count, and lost sponges during the course of the operation.

• Time spent in search of a missing sponge or otherwise reconciling a counting discrepancy

• A systems analysis of the O.R. during all counting procedures. Free-hand account of the counting procedure on a minute-to-minute basis which will include the following:

• Team members present in the O.R. at the time of the time of the count and those actively involved in the counting procedure.

• Concurrent activities in the O.R.

• Any influence of the counting activity on the activities of other team members. These will include but are not limited to: (1) a request by the surgeon or other team member not being met, (2) a repeated request for assistance by another team member.

• Any contributing factors. These will include but are not limited to: (1) original personnel not present in the O.R. due to a break or shift change, (2) conflict between team members, (3) communication breakdown.

• The time of the entrance and exit of all team members from the room.

• For intervention arm only, difficulties with the bar code technology or abandonment of the bar code technology will be recorded.

• Request for an X-ray to rule out retained sponge will be noted, even if the X-ray is cancelled or not performed due to the risks of prolonged anesthesia time.

• When an X-ray is requested, the following data points will be collected:

• Time X-ray request made

• Arrival time of X-ray technician in O.R.

• Time X-ray results are available

• When applicable, time X-ray request is cancelled and reason why

Secondary Outcomes (6)

• Team survey at completion of case

• To evaluate the ease and value of the Safety-Sponge System

• To determine the confidence of the OR team in the Safety-Sponge System

• To determine the team's evaluation of its own performance during the case. Specifically, whether the case went smoothly, whether there were any impediments to team performance, and if there was anyway that the team could have performed better.

• Medical record review.

Interventions

Bar coded sponge and scanner DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient Safety Technologies, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 12529464 BACKGROUND

• 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.

  PMID: 10635432 BACKGROUND

• 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.

  PMID: 16455323 BACKGROUND

Study Officials

• Atul A Gawande, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 27, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

US (1)