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.|
|ClinicalTrials.gov Identifier: NCT00282750|
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : January 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Bar coded sponge and scanner||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00282750
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Atul A Gawande, MD, MPH||Brigham and Women's Hospital|