Presentation
Characterizing Visibility-Related Safety Threats and Mitigation Strategies Before and After Adverse Events in Laparoscopic Surgery: An Analysis of Videos Recorded with the Operating Room Black Box
DescriptionBackground and Rationale
Laparoscopic surgery is an approach to abdominal and pelvic procedures that uses small incisions to insert surgical instruments into the body. Laparoscopic surgery has well-recognized benefits over traditional open surgery (i.e., which uses larger incisions to expose more of the patient’s anatomy), including a reduction in post-operative pain, blood loss, and recovery time due to the use of smaller incisions. However, the widespread adoption of laparoscopy introduces different challenges to surgical teams compared to open procedures. These laparoscopy-specific challenges lead to safety threats (ST; i.e., unexpected deviations from optimal processes that can increase the risk of harm to patients) in part due to the surgical site being visualized using a laparoscopic camera and displayed on monitors. Poor visibility during laparoscopic surgery negatively impacts surgical performance and can cause intraoperative adverse events (iAE). Laparoscopic-specific STs associated with visibility include: 1) a loss of depth perception due to a shift from a direct 3D view of the surgical site to an indirect 2D view for the operating surgeon, 2) malfunctions of the laparoscope and video display system, 3) poor laparoscope handling due to the dependence on a surgical assistant, requiring additional team communication, and 4) suboptimal viewing angle of the monitor (e.g., height or angle of the monitor may require adjustment, or height discrepancies between team members may complicate tool handoffs).
The visibility-related STs described to date emerge from the tasks involved with laparoscopic surgery, the equipment involved, and the interactions between the team and their environment. The Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 framework describes 6 categories of work system factors that influence healthcare processes and outcomes: person, tools and technology, tasks, physical environment, organization, and external environment. The use of the SEIPS framework enables researchers to gain a holistic understanding of how STs manifest.
Prior literature has recognized that visibility-related STs can lead to iAEs, but there is a dearth of evidence quantifying the proportion of iAEs that are visibility-related. Further, there has not been an analysis of the system factors that contribute to the occurrence of visibility-related STs, or the mitigation strategies (MSs) employed by surgical teams to address them.
Study Objectives
The objectives of the study are to 1) determine the proportion of iAEs associated with visibility challenges, 2) characterize the visibility-related STs leading to iAEs by system factor and whether they occur before or after the occurrence of iAEs, and 3) characterize the mitigation strategies used to address visibility-related STs by system factor and whether they occur before or after the occurrence of iAEs.
Methods
We describe an exploratory observational study currently in progress that involves analysis of video recordings captured by the Operating Room Black Box® (Surgical Safety Technologies Inc., Toronto, Canada), a device that collects and synchronizes sources of audio-visual data from the operating room. Observational data collected from the device originate from operating rooms dedicated to laparoscopic general and gynecological surgeries at two large academic hospitals and one large community hospital.
Intraoperative adverse events were identified by surgical analysts and classified using the SEVERE index, which identifies the type of event (e.g., bleeding, mechanical injury) and scores severity on a scale of 1 to 5. Intraoperative adverse events with severities or 1 or 2 (i.e., unlikely to lead to complications) were excluded. Human factors specialists review videos and manually transcribe events of interest into a Microsoft Excel spreadsheet with 1) a timestamp, 2) the clinicians involved in the event, 3) whether the event is visibility-related, 4) a ST or MS classification, and 5) the most appropriate SEIPS system factor that best describes the event. Events are further classified into subthemes within each system factor (e.g., a “ST, environment” instance may be coded with a subtheme of “suboptimal physical layout” or “distracting environment”).
Preliminary Results
As of October 16, 2023, 41 laparoscopic cases have been analyzed, and a further 29 laparoscopic cases are expected. The results for each objective are listed below:
1) A total of 38 iAEs were recorded, with 15 of the iAEs (15/38; 39%) associated with 37 visibility-related events (26 STs, 11 MSs).
2) The 26 visibility-related STs associated with iAEs had the following breakdown by work system factor:
• task STs (n=8; i.e., challenging patient anatomy),
• person STs (n=12; operating surgeon proceeding despite poor visibility, lack of communication between surgeons to adjust camera, poor camera control),
• environment STs (n=2; suboptimal video display height and angle),
• tool STs (n=4; i.e., lens-fogging, video display malfunction, lack of depth perception).
Twenty-four STs occurred prior to iAEs and 2 STs occurred after iAEs (e.g., a consequence of excess bleeding).
3) At least 16 of the 24 STs (67%) were addressed by subsequent MSs, but it was unclear whether additional STs were addressed by MSs as camera positions naturally change over time as it is handled by the assisting surgeon. Notably, some STs are inherent to laparoscopy and cannot be addressed with a mitigation strategy (e.g., lack of depth perception). The 11 MSs recorded were able to address 16 STs because some MSs influence multiple STs simultaneously. Mitigation strategies included staff adjusting video display setup (, n = 2), senior surgeon taking over control of the camera (n = 4), use of tools to improve visibility (n = 2; lens-defogging tools), operating surgeon providing verbal feedback to assisting surgeon (n = 3). Although 8 MSs (8/11; 73%) could have been acted upon prior to iAEs, all 11 MSs were only employed after the occurrence of an iAE. Efforts to address these visibility STs through communication were hindered or prevented in 6 instances due to multitasking by the assisting surgeon (n = 2) and an audibly distracting environment (n = 4).
Discussion
We found that 39% of iAEs identified were associated with visibility-related STs. MSs addressing visibility-related STs in cases with iAEs were triggered shortly after the occurrence of the iAEs, however 73% of the MSs could have been addressed earlier. This suggests that some iAEs were preventable, and the speed by which clinicians implemented them suggests they were aware that poor visibility was one of the primary contributors to the iAEs.
Given our findings suggest that some of the visibility-related iAEs could have been prevented with proactive MSs, we have outlined several potential reasons why these MSs were not instituted sooner. First, team communication or situational awareness may have been insufficient to trigger discussions about suboptimal monitor placements or laparoscopic camera handling. Second, it is possible that hierarchical social structures in the operating room may lead to team members recognizing visibility-related STs not acting proactively unless asked to do so. Third, suboptimal visibility does not completely prevent the operating surgeon from advancing the surgery in most cases. The operating surgeon may find that communicating their needs to the team is not worth the cost (e.g., delays their task, maybe MSs may only lead to marginal improvement) and ignores the visibility challenges despite the patient safety risk.
Further research is needed to understand the barriers to proactively addressing visibility-related STs. For instance, when do OR teams decide when visibility is poor? Does proactive team communication and shared mental models reduce visibility-related STs? Do innovative technologies such as flexible booms, adequate laparoscopic lens-defogging tools, and modern video display systems prevent visibility problems in surgery?
Laparoscopic surgery is an approach to abdominal and pelvic procedures that uses small incisions to insert surgical instruments into the body. Laparoscopic surgery has well-recognized benefits over traditional open surgery (i.e., which uses larger incisions to expose more of the patient’s anatomy), including a reduction in post-operative pain, blood loss, and recovery time due to the use of smaller incisions. However, the widespread adoption of laparoscopy introduces different challenges to surgical teams compared to open procedures. These laparoscopy-specific challenges lead to safety threats (ST; i.e., unexpected deviations from optimal processes that can increase the risk of harm to patients) in part due to the surgical site being visualized using a laparoscopic camera and displayed on monitors. Poor visibility during laparoscopic surgery negatively impacts surgical performance and can cause intraoperative adverse events (iAE). Laparoscopic-specific STs associated with visibility include: 1) a loss of depth perception due to a shift from a direct 3D view of the surgical site to an indirect 2D view for the operating surgeon, 2) malfunctions of the laparoscope and video display system, 3) poor laparoscope handling due to the dependence on a surgical assistant, requiring additional team communication, and 4) suboptimal viewing angle of the monitor (e.g., height or angle of the monitor may require adjustment, or height discrepancies between team members may complicate tool handoffs).
The visibility-related STs described to date emerge from the tasks involved with laparoscopic surgery, the equipment involved, and the interactions between the team and their environment. The Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 framework describes 6 categories of work system factors that influence healthcare processes and outcomes: person, tools and technology, tasks, physical environment, organization, and external environment. The use of the SEIPS framework enables researchers to gain a holistic understanding of how STs manifest.
Prior literature has recognized that visibility-related STs can lead to iAEs, but there is a dearth of evidence quantifying the proportion of iAEs that are visibility-related. Further, there has not been an analysis of the system factors that contribute to the occurrence of visibility-related STs, or the mitigation strategies (MSs) employed by surgical teams to address them.
Study Objectives
The objectives of the study are to 1) determine the proportion of iAEs associated with visibility challenges, 2) characterize the visibility-related STs leading to iAEs by system factor and whether they occur before or after the occurrence of iAEs, and 3) characterize the mitigation strategies used to address visibility-related STs by system factor and whether they occur before or after the occurrence of iAEs.
Methods
We describe an exploratory observational study currently in progress that involves analysis of video recordings captured by the Operating Room Black Box® (Surgical Safety Technologies Inc., Toronto, Canada), a device that collects and synchronizes sources of audio-visual data from the operating room. Observational data collected from the device originate from operating rooms dedicated to laparoscopic general and gynecological surgeries at two large academic hospitals and one large community hospital.
Intraoperative adverse events were identified by surgical analysts and classified using the SEVERE index, which identifies the type of event (e.g., bleeding, mechanical injury) and scores severity on a scale of 1 to 5. Intraoperative adverse events with severities or 1 or 2 (i.e., unlikely to lead to complications) were excluded. Human factors specialists review videos and manually transcribe events of interest into a Microsoft Excel spreadsheet with 1) a timestamp, 2) the clinicians involved in the event, 3) whether the event is visibility-related, 4) a ST or MS classification, and 5) the most appropriate SEIPS system factor that best describes the event. Events are further classified into subthemes within each system factor (e.g., a “ST, environment” instance may be coded with a subtheme of “suboptimal physical layout” or “distracting environment”).
Preliminary Results
As of October 16, 2023, 41 laparoscopic cases have been analyzed, and a further 29 laparoscopic cases are expected. The results for each objective are listed below:
1) A total of 38 iAEs were recorded, with 15 of the iAEs (15/38; 39%) associated with 37 visibility-related events (26 STs, 11 MSs).
2) The 26 visibility-related STs associated with iAEs had the following breakdown by work system factor:
• task STs (n=8; i.e., challenging patient anatomy),
• person STs (n=12; operating surgeon proceeding despite poor visibility, lack of communication between surgeons to adjust camera, poor camera control),
• environment STs (n=2; suboptimal video display height and angle),
• tool STs (n=4; i.e., lens-fogging, video display malfunction, lack of depth perception).
Twenty-four STs occurred prior to iAEs and 2 STs occurred after iAEs (e.g., a consequence of excess bleeding).
3) At least 16 of the 24 STs (67%) were addressed by subsequent MSs, but it was unclear whether additional STs were addressed by MSs as camera positions naturally change over time as it is handled by the assisting surgeon. Notably, some STs are inherent to laparoscopy and cannot be addressed with a mitigation strategy (e.g., lack of depth perception). The 11 MSs recorded were able to address 16 STs because some MSs influence multiple STs simultaneously. Mitigation strategies included staff adjusting video display setup (, n = 2), senior surgeon taking over control of the camera (n = 4), use of tools to improve visibility (n = 2; lens-defogging tools), operating surgeon providing verbal feedback to assisting surgeon (n = 3). Although 8 MSs (8/11; 73%) could have been acted upon prior to iAEs, all 11 MSs were only employed after the occurrence of an iAE. Efforts to address these visibility STs through communication were hindered or prevented in 6 instances due to multitasking by the assisting surgeon (n = 2) and an audibly distracting environment (n = 4).
Discussion
We found that 39% of iAEs identified were associated with visibility-related STs. MSs addressing visibility-related STs in cases with iAEs were triggered shortly after the occurrence of the iAEs, however 73% of the MSs could have been addressed earlier. This suggests that some iAEs were preventable, and the speed by which clinicians implemented them suggests they were aware that poor visibility was one of the primary contributors to the iAEs.
Given our findings suggest that some of the visibility-related iAEs could have been prevented with proactive MSs, we have outlined several potential reasons why these MSs were not instituted sooner. First, team communication or situational awareness may have been insufficient to trigger discussions about suboptimal monitor placements or laparoscopic camera handling. Second, it is possible that hierarchical social structures in the operating room may lead to team members recognizing visibility-related STs not acting proactively unless asked to do so. Third, suboptimal visibility does not completely prevent the operating surgeon from advancing the surgery in most cases. The operating surgeon may find that communicating their needs to the team is not worth the cost (e.g., delays their task, maybe MSs may only lead to marginal improvement) and ignores the visibility challenges despite the patient safety risk.
Further research is needed to understand the barriers to proactively addressing visibility-related STs. For instance, when do OR teams decide when visibility is poor? Does proactive team communication and shared mental models reduce visibility-related STs? Do innovative technologies such as flexible booms, adequate laparoscopic lens-defogging tools, and modern video display systems prevent visibility problems in surgery?
Event Type
Oral Presentations
TimeTuesday, March 268:50am - 9:10am CDT
LocationSalon A-1
Hospital Environments