2 The ERCP Room Brian C. Brauer and Steven A. Edmundowicz
The ERCP room can range from very basic to state-of-the-art. Whereas smaller institutions with low ERCP volumes often perform ERCP in the radiology department or operating room, most centers with a larger ERCP volumes perform ERCP in dedicated rooms within the endoscopy unit. The basic ERCP room requires a quality fluoroscopy unit with still-image capability in addition to standard endoscopic equipment. Major innovations in the field of interventional endoscopy have led to the development of multipurpose interventional rooms with the ability to combine endoscopic ultrasonography (EUS), cholangioscopy, pancreatoscopy, confocal endomicroscopy, and other interventions in combination with ERCP. A well-designed ERCP room is needed to accommodate this expansion in the procedural intensity of ERCP. In addition, changes in the patient population have led to the necessity to be able to perform ERCP on morbidly obese patients and those with altered anatomy using deep enteroscopy instruments. Many centers have moved to have anesthesia support for all ERCPs. The cumulative effect of these changes in the practice of ERCP has led to significant changes in the design of the typical ERCP room with the incorporation of new technology to benefit the patient, physician, and staff.
EVOLUTION OF THE ERCP ROOM The basic intent of ERCP has not changed. Endoscopic visualization of the ampulla and cannulation of the desired ductal system with high-quality radiographic imaging guiding the appropriate therapy is still the goal. In the great majority of cases the basic equipment is all that is needed to remove a stone or place a stent across uncomplicated strictures. What has changed is the potential complexity of ERCP, especially at tertiary referral centers. The need for high-quality radiographic imaging of focal pathology in larger patients has led to modified digital fluoroscopy equipment with improved resolution, reduced radiation exposure, and the ability to function continuously for long procedures without overheating. In addition, wider tables (>30 inches) capable of accommodating larger, heavier patients (≥450 lbs.) and space for anesthesia to assist in these procedures have become essential. Additional room space is also needed to accommodate larger beds and stretchers to allow for bariatric patients (Fig. 2.1). The use of a mobile or fixed C-arm system is often employed to improve visualization of the biliary tree by allowing the plane of examination to be altered to profile the bifurcation and selected ductal systems. Additional space for supplemental equipment for cholangioscopy, EUS, laser lithotripsy, electrohydraulic lithotripsy, deep enteroscopy, and other adjuvant techniques has increased the size of the typical advanced ERCP room. Space for anesthesia equipment has further increased the need for additional space at the patient’s head. All this, in combination with the need to accommodate morbidly obese patients and store a large variety of devices in close proximity to the patient, has increased the size of well-designed, advanced interventional endoscopy rooms to greater than 500 square feet.
STAFFING FOR THE ERCP PROCEDURE Staffing for ERCP procedures varies across the world. Typically, a physician and a minimum of two additional assistants are necessary. The first assistant (nurse or technician) stands immediately adjacent to the physician and operates devices such as guidewires and accessories. A sedation nurse or member of the anesthesia staff is positioned at the patient’s head and administers sedation or anesthesia while monitoring the patient throughout the procedure. Often, a second assistant (nurse or technician) assists in preparing devices for use and documents specifics of the procedure. In some settings a radiology technician is also needed to operate the radiographic equipment. In many centers, a trainee is often present. This creates a close working environment for the procedure with at least three individuals clustered around the patient’s head. A well-designed workspace makes this proximity tolerable and efficient.
ROOM LAYOUT The key to successful room design is early collaboration with all the disciplines that will be involved in performance and delivery of ERCP so that the room is functional and beneficial to all parties. Collaborative input from ERCP physicians, the endoscopy nursing team and technicians, anesthesia team, patient advocates, radiologists and technicians, radiation safety technicians, the ergonomics consultant, and the construction or design team can result in major design evolution to allow the final design to be optimized for the work group. The layout of a typical tertiary-level ERCP room is depicted in Fig. 2.2. The ERCP room can be divided into multiple work areas. The epicenter of the ERCP room is the fluoroscopy table. The physician stands adjacent to the patient’s head while performing ERCP. In this room design the physician also has direct access to the radiographic equipment controls that allow movement of the fixed C-arm or table to obtain the optimum radiographic imaging. The first assistant’s workspace is immediately to the right of the physician. Space for a trainee is preferably located immediately to the physician’s left side. Adjacent to the first assistant’s work space is a preparation area for a second assistant with a countertop or movable table to prepare devices. This space should be immediately adjacent to the in-room storage of the most often used devices. Directly above the patient’s head is space for the sedation nurse or anesthesia team member. This space also includes room for all necessary medications, monitoring equipment, and resuscitative equipment. When using anesthesia, often there are two carts: the anesthesia machine at the patient’s head, and a secondary cart for medication and equipment storage, which must be within easy reach of the anesthesia provider. An optimal room design will allow ample space for these pieces of equipment, and easy access to all spaces during the procedure. Ideally, adequate additional space for radiograph review and report generation should be available. This space may be behind a protective lead glass screen or in another space altogether. In some configurations, a separate control room space for
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SECTION I General Topics
FIG 2.1 Large-capacity room door and extra space around the radiography
FIG 2.3 The endoscopic equipment boom allows easy access to the
table allow for transfer of large patients. There is easy access to the back of the table to facilitate movement of sedated patient after the procedure.
endoscope processor, the light source, and other key equipment, including the electrosurgical generator, CO2 insufflator, and water irrigator. The boom keeps wires and electrical cords organized and off the floor.
Monitor panel
Physician workspace Endoscope processor boom Storage cabinets
First assistant workspace Preparation table
Pre/post physician workspace
Anesthesia/sedation nurse workspace
Patient
Anesthesia cart
Anesthesia machine
C-arm
Second assistant workspace Storage cabinets
Countertop
FIG 2.4 Adjustable monitor boom that can be adjusted to a height suitable for the endoscopist and assistants. The upper monitors can display inputs from a variety of sources.
FIG 2.2 Drawing of a modern interventional endoscopy room with workspace for the endoscopist, first assistant, anesthesia or sedation nurse, and second assistant. The drawing also depicts the endoscopist preprocedure and postprocedure work area, suspended bank of monitors, and endoscopic equipment boom.
the radiographic equipment may be necessary; alternatively, if required, a radiation technologist may be in the room. The physician should have immediate access to all the endoscopic and radiographic controls that are necessary to complete ERCP. The use of ceiling booms greatly facilitates the placement of processors and devices in close proximity to the physician and assistant with minimal cords or tubing on the floor of the procedure room (Fig. 2.3). The boom can be used to house the endoscope processor and light source, electrocautery unit, and other ancillary equipment such as a CO2 insufflator, water irrigation system, EUS equipment (if compact), and other devices. The typical room design has the endoscopic and radiographic monitors directly across from the physician to allow a direct line of sight (Fig. 2.4). The monitors should be adjustable in height to accommodate physicians of various heights and be freely mobile during patient positioning and procedure preparation. An ancillary monitor to display additional images or information such as choledochoscopy, manometry, EUS, or even patient vital signs greatly facilitates the completion of procedures without awkward head angulation. Rooms with video integration systems allow multiple video sources to be displayed on the monitor array in the patient room. This can be
particularly helpful if viewing an imaging study (computed tomography and magnetic resonance imaging) is necessary during the procedure. The monitors should be in the line of sight of the first assistant as well to allow coordinated device manipulation with endoscopic and/or fluoroscopic guidance. There should be ample space for ancillary devices (EUS processors, choledochoscopy devices, etc.) to be placed in the room in close proximity to the physician. In larger centers with multiple ERCP rooms, infrequently used equipment may be placed on carts that can be moved from room to room. In the overall layout of the room, there should be sufficient space for patients to be moved on large stretchers or beds. Mobile ceiling-mounted booms greatly facilitate patient movement. For improved efficiency, a portal for endoscope cleaning should be considered to allow rapid movement of used endoscopes to the cleaning room to facilitate room turnover. If this is not available, appropriate containers for rapid and safe transport of used endoscopes should be kept in the ERCP suite adjacent to the endoscope reprocessor (Fig. 2.5).
RADIOLOGIC IMAGING EQUIPMENT The selection of a radiologic system is one of the most important and expensive decisions to be made during ERCP room design or upgrade. Most hospital systems have purchasing agreements and alignments with specific vendors, and all major manufacturers of radiology and fluoroscopy rooms have a unit that can be well adapted to ERCP. There are
CHAPTER 2 The ERCP Room A
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B
FIG 2.5 (A) Portal to cleaning and cold sterilization area. (B) Trays are then covered, and following scope use, these trays are used to immediately transfer contaminated equipment back to the reprocessing area.
TABLE 2.1 Available Fluoroscopy Units Company
C-arm
Fixed Unit
Flat Detector
Website
Philips Seimens Omega GE Toshiba
Y Y N Y N
Y Y Y Y Y
Y Y Y Fixed unit only Y
usa.philips.com usa.healthcare.seimens.com omegamedicalimaging.com www3.gehealthcare.com medical.toshiba.com
also dedicated ERCP systems and portable digital C-arm systems. A review of the principles of radiographic imaging and different imaging systems is found in Chapter 3. The transition to digital imaging systems in the last decade has greatly simplified image processing and storage while essentially eliminating the need for in-room radiologic support. The selection of a radiologic system is dependent on many factors, including case volume, type, and patient mix. For low-volume, relatively simple ERCP cases, many available systems are adequate. For high-volume, complex case work (American Society for Gastrointestinal Endoscopy [ASGE] grade of difficulty type 2 or 3 cases),1 a high-end dedicated fixed C-arm is often best. High-end fixed rooms have sufficient power and imaging systems to optimally image obese patients and complex strictures and allow visualization of devices and guidewires in situations where mobile units are inadequate. In addition, pulse rates may be adjusted for more rapid image acquisition during difficult maneuvers while still avoiding continuous fluoroscopy. Digital flat panel detectors provide improved image quality, have durability over traditional analog image intensifiers, and allow magnification of the image without increasing radiation dose. They are available on most fixed fluoroscopy systems and many portable C-arm platforms, but at a substantially increased cost. A list of available fluoroscopy units is provided in Table 2.1. In
addition, the radiation generation and cooling properties of fixed units allow for prolonged procedure times without overheating or image degradation. Investment in a fixed fluoroscopy room also allows the room design to include dedicated shielding and radiation protection for the staff. The addition of a radiation-attenuating drape around the image detector has been shown to significantly decrease the radiation dose to staff during ERCP.2 The use of ceiling-mounted and table-mounted shielding can greatly reduce radiation scatter and staff exposure (Fig. 2.6a). Portable shields on wheels may also be integrated to provide additional shielding (Fig. 2.6b). Building codes and hospital safety mandates may also require shielding of the walls and doors of the suite.
ROOM INTEGRATION SYSTEMS Video integration systems have evolved to give the operator control over the numerous video inputs used in a state-of-the-art interventional room. Several manufacturers sell integrated units that can be customized for a specific room or unit layout. In a well-designed integration system, video inputs from multiple sources can be placed on the main imaging display in the room (Fig. 2.7). The typical integration system has multiple inputs for EUS, choledochoscopy, or any other video signal to be placed
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SECTION I General Topics A
B
FIG 2.6 (A) Ceiling-mounted lead shielding that can be positioned to shield those close to the radiation source. (B) Rolling shield on wheels that can be used in units without ceiling-mounted shielding.
video integration system, it is important to have the flexibility to add new inputs to the system as new technology becomes available.
ENDOSCOPIST WORK AREA Intraprocedure
FIG 2.7 Video integration system touch screen monitor that allows any video input to be placed on one of four video monitors in direct view of the endoscopist and assistant.
into the system for recording and display on the in-room monitors, and can be controlled by the physician or assistant directly from the room. More sophisticated systems may allow for inputs from the hospital radiology imaging system and electronic medical record (EMR) so that radiology images from diagnostic studies, as well as text, images, and other information from the EMR, can be displayed in the procedure room. Some integration systems allow for recording and editing of inputs to create compilation recordings or for broadcasting of multiple inputs to a local or even distant conference room. When planning a
The endoscopist workspace during the procedure should be ergonomically designed to be comfortable, shielded from radiation, and efficient.3,4 A soft floor surface or cushioned mat will help prevent operator fatigue that results from prolonged standing.5 The main room video monitors should be directly in front of the endoscopist at eye level to reduce the need for head rotation and to minimize neck strain.6 The monitors should be adjustable in height and positioned to simultaneously visualize endoscopy and fluoroscopy without the need for significant head movement (eye shifting only) (Fig. 2.8). The floor of the endoscopist workspace can become crowded with pedals needed to operate the radiology equipment, electrocautery units, irrigators, electrohydraulic lithotripsy units, and lasers. Having a set orientation for the different activation pedals can be helpful and easily integrated into the staff room setup procedure.
PREPROCEDURE AND POSTPROCEDURE WORK AREA An extensive amount of preparation is necessary before and after performance of interventional endoscopic procedures (see Chapter 10); a well-designed ERCP suite provides a comfortable and convenient
CHAPTER 2 The ERCP Room
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FIG 2.10 Anesthesia space with anesthesia cart, medication cart, and space for anesthesia provider to sit or stand.
FIG 2.8 Adjustable boom positioned so that it is in direct line of sight for endoscopist.
and access to the opposite side of the fluoroscopy table. In addition, a bariatric patient lift may be required if a high volume of bariatric procedures are performed. The anesthesia or sedation work area is located at the head of the bed and allows direct access to the patient’s airway. There is significant institutional variability to sedation and anesthesia approaches for ERCP. The approaches range from general anesthesia with airway intubation to deep sedation. Anesthesia issues related to ERCP are covered in detail in Chapter 6. The anesthesia or sedation space contains room for a medication cart, airway equipment, and monitors to include CO2 capnography and pulse oximetry (Fig. 2.10). Many units have smallersized anesthesia machines available for the ERCP room that allow administration of general anesthetics and high-flow (100%) O2. Airway management equipment, including nasal airways, masks, and bag valve masks for ventilation, endotracheal tubes, laryngoscopes, and other intubation tools, should be readily available. In some centers a sedation nurse monitors the patient’s airway and provides intravenous moderate sedation.
NURSING AND TECHNICIAN WORK AREA
FIG 2.9 Separate physician workspace adjacent to ERCP suite.
workspace for record review, EMR access, radiograph review, report generation, and phone or electronic communication (Fig. 2.9). This workspace is ideally located adjacent to the procedure space to allow easy communication during the preprocedure and postprocedure period.
ANESTHESIA/SEDATION WORK AREA The obesity epidemic has led many centers to modify their approach to room design. The use of fixed fluoroscopy systems with wider tables (30 inches plus) and increased weight limits (≥450 lbs.) has become the norm. Access to the radiography table with larger stretchers and beds has required room designs with additional space. Transferring the sedated or recovering patient from the fluoroscopy table to the stretcher or bed can be challenging and should be facilitated with sliding boards
The workspace necessary for those individuals assisting the endoscopist is critical to the success of the ERCP room. This workspace requires ample room for device preparation, exchange, and equipment and accessories. This can be accomplished with a countertop or a movable table that can be placed in position next to the endoscopist to allow device preparation. This area should be immediately adjacent to the in-room storage space for the devices and accessories that may be needed during an interventional procedure. The storage space is ideally protected against splash contamination using glass doors or rolling panels (Fig. 2.11). The in-room storage space should allow for a small number of each type of accessory needed for all procedures, and a larger storage area should be located remotely in the endoscopy facility for additional devices from which the in-room supply can be restocked. Barcode scanners, dedicated chips containing specific information about device and par levels, and even commercial inventory management vendors may be used to maintain adequate and predictable inventory. Direct inventory systems that are placed in the rooms and charge supplies as they are used are also available and function in a similar manner to medication-dispensing systems. Space for additional equipment such as EUS and choledochoscopy systems has become vital for complex interventional procedures. These systems often need to be in close proximity to the patient’s head and occupy a portion of the first assistant’s space. Ample room size to allow
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SECTION I General Topics
A
B
C
FIG 2.11 (A) Cabinet with rolling door for supply storage in ERPC suite. (B) Same cabinet in panel A with rolling door opened. (C) Built-in glass cabinets for supply storage in ERCP suite.
FIG 2.12 Dedicated storage adjacent to ERCP suite. Large equipment is kept in a designated location where it can easily be found.
movement around this equipment to facilitate device passage, specimen handling, and other duties is key to successful room design and use. Ancillary equipment must be stored close to the ERCP room so that it can be accessed relatively quickly (Fig. 2.12).
ERGONOMICS Room ergonomics that benefit the staff are also essential. Cushioned flooring, easy visualization of monitors at eye level, protective radiation shielding, and chairs for sitting during long cases are all beneficial and help prevent work-related fatigue and injury. Lightweight lead, appropriately fitted for the individual, can greatly reduce fatigue and muscle strain and is an important investment for any high-volume unit. Several manufacturers also offer real-time dose management systems that can help tailor exposure to both the patient and the staff and help guide shielding and radiation practices (RightDose [Siemens AG, Muenchen, Germany]; DoseWise Portal [Philips North America, Andover, MA]; RaySafe X2 [Unfors Raysafe, Inc., Cleveland, OH]).
FIG 2.13 Portable ERCP accessory cart. Commonly used devices can be kept in this cart and inventoried in the same manner as a procedure room. This cart has been adapted to allow lead aprons to be hung from the back for easy transport.
CHAPTER 2 The ERCP Room Room design that creates close proximity of key items (devices, specimen repository, endoscope cleaning site) reduces the number of steps and fatigue.
MISCELLANEOUS ISSUES Even with a high-volume dedicated interventional room with anesthesia support, occasional ERCPs will need to be done in an operating room, bedside in the intensive care unit (ICU), and in interventional radiology suites and other remote locations. The ERCP room layout can be achieved in these areas with mobile endoscopy carts, monitors, and a travel equipment cart that holds essential ERCP equipment (Fig. 2.13). This
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allows replication of the space and roles defined in the typical room in almost any location. When performing procedures in the operating room, using a room equipped for laparoscopic procedures is beneficial. The video for endoscopic and fluoroscopic view monitors can be transmitted to the monitors normally used for laparoscopic image visualization, thus placing the image in a more ergonomically correct position for the endoscopist and staff. The travel equipment cart can also be used for additional device storage and supplement the in-room storage when periods of increased device use occur. The complete reference list for this chapter can be found online at www.expertconsult.com.
CHAPTER 2 The ERCP Room
REFERENCES 1. Cotton PB, Eisen G, Romagnuolo J, et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011;73:868–874. 2. Muniraj T, Aslanian HR, Laine L, et al. A double-blind, randomized, sham-controlled trial of the effect of a radiation-attenuating drape on radiation exposure to endoscopy staff during ERCP. Am J Gastroenterol. 2015;110:690–696. 3. Pedrosa MC, Farraye FA, Shergill AK, et al. Minimizing occupational hazards in endoscopy, personal protective equipment, radiation safety, and
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ergonomics: technology status evaluation report. Gastrointest Endosc. 2010;72:227–235. 4. ASGE Ensuring Safety in the Gastrointestinal Endoscopy Unit Task Force, Calderwood AH, Chapman FJ, et al. Guidelines for safety in the gastrointestinal endoscopy unit. Gastrointest Endosc. 2014;79:363–372. 5. Shelly A. Best practices: ergonomic standing surfaces for workers. Occup Health Saf. 2005;74(128):130–134. 6. Shergill AK, McQuaid KR, Remped D. Ergonomics and GI endoscopy. Gastrointest Endosc. 2009;70:145–153.