HealthyNCT00282750
The Bar Coded Sponge Study
A study testing Bar coded sponge and scanner in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bar coded sponge and scanner
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomised Clinical Trial of a Bar-Coded Safety Sponge System
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.
Read the 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
- Being tested
- Bar coded sponge and scanner
- Keywords
- "Surgery"[MeSH], "Surgical Sponges"[MeSH], "Automatic Data Processing"[MeSH]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bar coded sponge and scannerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient Safety Technologies, Inc.
- Investigators
- Atul A Gawande, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282750
- Sponsor's protocol ID
- 2005-P-002344
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2006
- Last updated
- 14 Jan 2010
- Results posted
- No
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. doi: 10.1056/NEJMsa021721.
PubMed 12529464Recommended 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.
PubMed 10635432Christian 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.
PubMed 16455323
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial of a Bar-Coded Safety Sponge System
- ClinicalTrials.gov ID
- NCT00282750
- Acronym / sponsor ID
- 2005-P-002344
- Conditions
- Healthy
- Keywords
- "Surgery"[MeSH], "Surgical Sponges"[MeSH], "Automatic Data Processing"[MeSH]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient Safety Technologies, Inc.
- Study start
- Mar 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bar coded sponge and scanner | Device | – |
Primary outcome
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
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Background: PubMed 12529464Gawande 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.
- Background: PubMed 10635432Recommended 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.
- Background: PubMed 16455323Christian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul A Gawande, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bar coded sponge and scanner in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of time per operating room staff member (circulating nurse and scrub technician) spent on sponge and instrument counts.. The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.