Working... Menu

The Bar Coded Sponge Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282750
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : January 14, 2010
Patient Safety Technologies, Inc.
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Device: Bar coded sponge and scanner Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Clinical Trial of a Bar-Coded Safety Sponge System
Study Start Date : March 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Primary Outcome Measures :
  1. The amount of time per operating room staff member (circulating nurse and scrub technician) spent on sponge and instrument counts.
  2. The phase of the counting episode (initial counts, objects added to field, closing counts, or repeat counts).
  3. 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.
  4. Time spent in search of a missing sponge or otherwise reconciling a counting discrepancy
  5. 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:
  6. Team members present in the O.R. at the time of the time of the count and those actively involved in the counting procedure.
  7. Concurrent activities in the O.R.
  8. 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.
  9. 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.
  10. The time of the entrance and exit of all team members from the room.
  11. For intervention arm only, difficulties with the bar code technology or abandonment of the bar code technology will be recorded.
  12. 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.
  13. When an X-ray is requested, the following data points will be collected:
  14. Time X-ray request made
  15. Arrival time of X-ray technician in O.R.
  16. Time X-ray results are available
  17. When applicable, time X-ray request is cancelled and reason why

Secondary Outcome Measures :
  1. Team survey at completion of case
  2. To evaluate the ease and value of the Safety-Sponge System
  3. To determine the confidence of the OR team in the Safety-Sponge System
  4. 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.
  5. Medical record review.
  6. Medical record reviews will be performed to follow up on the patients' status sixty days after the surgical procedure. The presence or absence of retained sponges or instruments will be the measured outcome for chart review.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282750

Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Patient Safety Technologies, Inc.
Layout table for investigator information
Principal Investigator: Atul A Gawande, MD, MPH Brigham and Women's Hospital

Layout table for additonal information Identifier: NCT00282750     History of Changes
Other Study ID Numbers: 2005-P-002344
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Brigham and Women's Hospital:
"Surgical Sponges"[MeSH]
"Automatic Data Processing"[MeSH]