The Bar Coded Sponge Study - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital Patient Safety Technologies, Inc.
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00282750

Purpose

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	Intervention
Healthy	Device: Bar coded sponge and scanner

MedlinePlus related topics: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Clinical Trial of a Bar-Coded Safety Sponge System

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

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 Outcome Measures:

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.
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.

Estimated Enrollment:	350
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282750

Locations

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.

Investigators

Principal Investigator:

Atul A Gawande, MD, MPH

Brigham and Women's Hospital

More Information

Publications:

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.

[No authors listed] 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. No abstract available.

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.

Study ID Numbers:	2005-P-002344
Study First Received:	January 26, 2006
Last Updated:	September 29, 2006
ClinicalTrials.gov Identifier:	NCT00282750
Health Authority:	United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:

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

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009