Vanderbilt University Department of Biomedical Engineering BME 273 Improving Simulations in the Post Anesthesia Care Unit Written by: Alyssa Z. Cherif Group 28, Department of Biomedical Engineering Advisors: Dr. Matt Weinger, Ray Booker, Bobby Gibbons, Dr. Paul H. King Submitted: April 24, 2007 1 ABSTRACT The Post Anesthesia Care Unit Simulation Center was created to allow medical and nursing students to practice a variety of procedures on a simulated patient, SimMan. To efficiently simulate all possible scenarios that could arise in the PACU, it is necessary to provide a full range of pulmonary function. At the start of this project, there were only two options for lung size: fully functioning or completely collapsed. The overall goal for this project was to allow for a range in the available volume in SimMan's lungs and to have it be externally controlled; simulating an obstructive pulmonary disease. This goal was to be achieved in the most efficient and inexpensive manner possible. A prototype was built by inserting a saline bag into one of SimMan's lungs; this saline bag had a tube extend outside the body. The tube can be injected with air using a syringe, allowing for total external manipulation of available lung volume. Data was collected from the screen of the anesthesia monitor. To effectively simulate an obstructive pulmonary disease, there must be a decrease in the amount of air expired by the lung per breath. This was achieved, as shown by the steady decrease in the volume of air expired as the saline bag volume was increased, and hence available lung volume decreased. Also, the pressure needed to push air in and out of the lungs increased with the volume of air added to the saline bag; the relationship is well-represented by a third order polynomial. Overall, this prototype was extremely inexpensive to build and it successfully simulates an obstructive pulmonary disease. 2 INTRODUCTION After undergoing a surgery involving anesthesia, the patient is sent to the Post Anesthesia Care Unit, or the PACU. Because general anesthesia affects the entire body, postoperative effects tend to appear, the most common being pulmonary complications. The PACU Simulation Center was created to enable medical and nursing students to practice a variety of procedures on a simulated patient called SimMan. SimMan has several working bodily systems, including fully functioning lungs. His vital statistics can be externally controlled using a program called SimQuest. SimQuest can alter his statistics such as blood pressure and heart rate, and then display them on a monitor inside the Simulation Center. At the start of this project, there were only two options for lung size: fully functioning or completely collapsed. To efficiently simulate all possible scenarios that could arise in the PACU, it is necessary to provide a full range of pulmonary function. The primary way in which pulmonary function is assessed is by volume measurements (Sherwood 479). The most important of these is tidal volume, which represents the amount of air entering and leaving the lungs in the span of one breath. The expiratory reserve volume is the amount of air which can be expired after normal exhalation, with maximum force of the expiratory muscles. The residual volume is the amount of air left in the lung after exhalation, included after maximally forced exhalation. Functional residual capacity is the amount of air in the lung after a normal, involuntary expiration; this is calculated as the sum of expiratory reserve volume and residual volume. The vital capacity is the largest possible volume change in a single breath in the lungs, after the patient maximally inhales and then exhales. The total lung capacity is the largest possible amount of air that can be held in the lungs and is calculated as a sum of residual volume and vital capacity. The final 3 measurement is FEV1, forced expiratory volume in one second; this is calculated as the amount of air exhaled in the first second of a vital capacity measurement (Sherwood 478). There are two types of respiratory dysfunctions which can be diagnosed using these volume measurements: obstructive and restrictive pulmonary diseases. A patient with an obstructive lung disease tends to experience problems with full expiration. Obstructive lung disease patients exhibit standard values of total lung capacity, and increased levels of functional residual capacity and residual volume; they also show a decrease in vital capacity and FEV 1. These measurements show that although there is a normal amount of air going into the lung, the patient presents with difficulty in reaching full expiration: there is always some extra air left inside the lung (Sherwood 479). Patients with restrictive lung diseases suffer from a loss of compliance, causing problems filling their lungs. These patients show reduced total lung capacity and vital capacity, caused by their inability to properly expand their lungs. The residual volume is typically normal, while the FEV1 is elevated. The fourth leading cause of death in the United States is chronic obstructive pulmonary disease, or COPD1. The leading cause of COPD is smoking and it tends to affect women more often than men1. COPD is an irreversible obstruction of air expired by the lungs. The damage typically worsens with time, causing a continual decrease in air exhaled2. In certain cases, spasms cause further blockage of the airways. The severity of COPD is determined by the amount of both airway blockage and tissue damage. COPD refers to one of two diseases, either chronic bronchitis or emphysema. Chronic bronchitis results in inflamed bronchi and an overproduction of respiratory mucus, sputum. It is 1 2 http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35020 http://www.medicinenet.com/chronic_obstructive_pulmonary_disease_copd/article.htm 4 the sputum that leads to the progression of the disease and the difficulty in reduction of inflammation. The second COPD, emphysema, is an enlargement of the alveoli. This enlargement damages the alveoli walls, causing tissue loss as well as a decrease in functional breathing3. The overall goal for this project was to allow for a range in available volume in SimMan's lungs and to have it be externally controlled, thereby simulating an obstructive pulmonary disease; this was to be achieved in the most efficient and inexpensive manner possible. To insure that the prototype built actually simulated an obstructive pulmonary disease, data was collected using the anesthesia machine monitor, as can be seen in Figure 1. Monitor of the anesthesia Figure 1. Monitor of the anesthesia machine. machine.. The screen shows several volumes including VE, VT and VTE. VE is the amount of air expired over a minute, and is measured in liters per minute. VT is the tidal volume; in this case, it is the amount of air delivered to the patient per breath. VTE is the amount of air actually expired in each breath; in an obstructive pulmonary disease, this value should be less than the tidal volume. The final measurement important to the data collection in this project was PMAX, the pressure needed to get air in and out of the lungs; this value should increase in an effectively simulated pulmonary dysfunction. METHODOLOGY Several requirements were considered before embarking on this project. First, the prototype must be able to withstand regular SimMan operations, including cardiopulmonary resuscitation 3 http://www.diseases-explained.com/COPD/home.html 5 (CPR). The prototype must also fit inside SimMan's chest cavity and cause as little disturbance as possible. SimMan, like a regular human being, operates at a range of pulmonary parameters; the prototype must work within these ranges. The lung must always be airtight, so the prototype should not allow air leakage. The prototype should be efficient, inexpensive and easily repairable. Most importantly, the prototype should allow for external control of the lung volume. When first exploring possible options, measurements were made to get base knowledge of SimMan's lungs. Knowing the available lung volume is vital when manipulating the lungs. To make the measurement, the lung was filled with water. Then, the water was poured into a graduated cylinder. The final volume of water that fully expanded the lungs was found to be 1263ml. After this volume measurement, length was then considered. The bronchus was found to be 11.4cm with an inner diameter of 15.9mm and an outer diameter of 19.1mm. These measurements were all considered while selecting the best possible method. As mentioned, the prototype must work at the full range of lung parameters. Each parameter has a range specified by the person operating the anesthesia machine; the actual values are displayed on the ventilator screen. When SimMan's values go outside the range, alarms alert the user. Typically, SimMan's tidal volume is in the range of 400 – 600ml, although 600ml is a bit high for normal operation. The ranges of VE and VTE are 3.8 – 5.8 L/min and 140 – 1000ml, respectively. Finally, the Plimit is usually set at 40cm H2O, which can be adjusted higher or lower, depending on a given situation. The first idea considered was a valve, to be placed either in or around the bronchus of the lung. This would easily allow variable amounts or air to enter the lung, and it would take up minimal space within the chest cavity. To implement this method, a solenoid with variable resistance would be attached to the inside of the lung bronchus; the resistance of the solenoid 6 could be externally manipulated. Unfortunately, this method would change the lung resistance as opposed to its volume; solenoids are also generally expensive and fragile. This prototype would most likely not withstand daily SimMan activities, namely CPR, so this idea was rejected. The second idea was a weight of some sort to be placed atop the lung, inside the chest cavity. The weight would be of variable mass; as the mass of the object changed, so would the internal volume of the lung. This method would allow for a large range of lung volumes, but it also brought up several concerns. First, if the weight was moved during operation, the lung could be completely collapsed; it would not be able to be repaired until the end of the simulation. The chances of the object moving would be high due to CPR and other chest compressions. Second, while the object could be externally controlled, it would take up a great deal of space within the chest cavity. Due to these possible complications, the weight idea was overruled. The final idea was to insert a balloon of some sort inside the lung; this balloon would have a tube to extend outside the lung and chest cavity to allow for external manipulation. During balloon expansion, available lung volume would decrease. As long as a balloon with dimensions smaller than those of the lung could be found, the standard parameters should be achieved. Hence, this method was the optimal choice, and taken to the next level. The first step to making the prototype was finding a balloon to fit comfortably inside the lung. Saline bags come in a variety of sizes are quite inexpensive. A 1000ml saline bag was chosen because its volume was closest to that of the lung. Due to this similarity, the prototype would be able to simulate a deflated lung, a fully expanded lung and every volume in between. Another convenience of saline bags is that they have tubing that fits directly into their own tubes. After acquiring the saline bag and its tubing, it needed to be inserted into the lung. The saline bag has a 12.1cm width, making it too wide to be fit through the bronchus. A 7 bronchoscope was used to examine the interior of the lung; it was discovered that the bronchus could not be removed. The final decision was to make a slit at the bottom of the lung, and slip the saline bag in through this hole. The tube receiver of the saline bag was placed at the top of the lung, at the rear. This positioning allows for the tubing that attaches to the bag to exit the chest cavity via holes previously drilled in SimMan's back. Once the saline bag was placed inside the lung, the next concern was resealing the lung and ensuring that it stay airtight. At first, silicon glue was suggested because this type of glue typically works to seal vinyl, the material of which the lung is made. After setting for 36 hours, the two sides of the lung did not adhere. The next method tried was a heat gun. Heat was applied to the bottom of the prototype. Due to prolonged exposure without any cooling, the lung became extremely singed. This led to over-sealing and a great reduction in available lung volume. The first prototype was discontinued and used later for extra material. Upon insertion of the saline bag into the second prototype, the heat gun was used again. This time, intermittent blasts of hot and cold air were administered to prevent over-sealing. Although this method worked, it took at exceptional amount of time and it was far from flawless. Hence, a new type of glue was sought after. This time, a flexible adhesive was used; this glue works on vinyl, fabric and plastics. This glue was completely effective and provided an appropriate amount of flexibility. The next step was to allow access to the saline bag from the exterior of the lung. The saline bag's tubing measures a 6.35mm diameter. A hole was punctured in the rear of the lung roughly of similar size. Due to the suppleness of the vinyl lung, it tore easily. To cover up any exposed areas, additional pieces of vinyl from the primary prototype were glued around the saline bag tubing, using the same flexible adhesive. To secure these additional pieces, rubber 8 washers were positioned on the tubing that exits the lung. The washers have a 6.35mm inner diameter, so they fit perfectly. After the second prototype was completed, it was taken to the simulation center for testing. Once hooked up to SimMan, the anesthesia machine was turned on. At this point, the bellows began pumping air at the specified VT. The bellows constantly returned to maximum height, guaranteeing that the prototype was in fact airtight. The first trial was then run to begin collecting data. The prototype had been placed on the right side of the chest cavity; this caused the right side to sit a bit higher. The saline tubing attached to the prototype was pulled through the hole in SimMan's back. This tubing was rather bulky due to parts that are only needed for intended saline bag use; so, these parts were removed. After removing a big of the bulkiness and rearranging a few items, the chest cavity sat lower and new trials were begun. RESULTS During all trials, VT was set to 450ml. The frequency was set to 12 breaths per minute and the inhale to exhale ratio (I:E) was set as 1:2. Finally, the Plimit was set at 40cm H2O and the PEEP was off. At the start of the first trial, air was syringe. After 180cm3 of air was added to the saline bag, a linear trend was no longer observed; Maximum Pressure (cm H20) added in 60cm3 increments, using a 60cm3 Trial 1, Pressure versus Air Added 40 35 30 25 20 15 10 5 0 0 3 so, air was added 10cm at a time. The saline bag was inflated until it reached 840ml. The results can be seen in Figure 2. 200 400 600 800 Volume of Air Added (cc) Figure 2. Results from trial 1, pressure exerted by the anesthesia machine versus volume of air added to the saline bag. 9 Figure 2 shows the relationship between pressure observed and the volume of the saline bag. Again, the pressure is the amount needed in order to inflate and deflate the lungs. With a third order polynomial trendline applied to this data, there is an R2 value of 0.9942. This is a terrific R2 value, showing that this relationship is well-represented by a third order polynomial. After the saline bag was filled to 840ml, the air was slowly pulled out of the bag, still using the syringe. The results from this drainage Trial 1, Pressure versus Air Removed was much sharper than when the air was injected into the saline bag. At the start, the pressure Maximum Pressure of Lung (cm H20) can be seen in Figure 3. The change in pressure 40 35 30 25 20 15 10 5 0 0 200 values dropped at 2cm H2O per 60cm3 air removed. As the saline bag volume decreased, 400 600 800 Volume of Air Removed (cc) Figure 3. Trial 1, relationship between pressure exerted by the anesthesia machine and air removed from the saline bag. the drop became less sharp. An interesting point is that the final pressure value of the deflated saline bag was lower than the pressure value initially observed at the start of the first trial. The next trial was conducted after the readjustment of objects inside of SimMan. This was the point when all extra bulkiness was removed from the tubing and the two sides of the chest were made to be level. Figure 4 shows the data from the second trial. Another important difference between this trial and the first is that beginning. When a third degree polynomial trendline was applied to this data, the R2 value Maximum Pressure of Lung (cm H20) the air was added in 10cm3 increments from the Trial 2, Air Added vs. Pressure 35 30 25 20 15 10 5 0 0 100 200 300 400 500 Volume of Air Added (cc) increased to 0.9963. This decrease in error is most likely due to the steady addition of air. It is Figure 4. Trial 2, relationship between pressure exerted by the anesthesia machine and air removed from the saline bag. 600 10 also most likely due to the lower pressure values, Relationship Between Saline Bag Volume and Lung Pressure Maximum Pressure (cm H20) caused by a more comfortably arranged chest cavity. A direct comparison between the two trials can be seen in Figure 5. 33 Trial 1 28 Trial 2 23 18 0 200 400 600 800 Volume of Air Added (cc) During the second trial, VTE was also Figure 5. Comparison of trials 1 and 2. monitored. As the volume of the saline bag and pressure needed to inflate the lungs both increased, Air Expired by Lung as Compared with Volume Increase in Saline Bag Volume Expired by Lung (ml) VTE decreased. The decline can be seen in Figure 6. With a third order polynomial trendline applied, 2 the R value is 0.9703; this shows that VTE is less 360 350 340 330 320 310 0 100 200 300 400 500 600 Volume of Air Added (cc) proportional to a change in saline bag volume. The VTE values observed while SimMan Figure 6. Relationship between air expired by the lung and volume of the saline bag. was attached to the prototype lung were as much as 132ml less than the VT of 450ml. To test if this was related to the prototype design, the VTE values were recorded again while both of the normal lungs were attached to SimMan. The observed VTE values were in the range of 360 – 370ml. While these values are closer to 450ml, they are still considerably smaller. Interestingly enough, when the normal lungs are in place, the PMAX is observed to fluctuate between 25 and 26cm H2O. So, while the VTE is slightly closer to the VT, the PMAX values are those observed when the lung is nearly halfway filled by the saline bag. This prototype is easily marketable as there are many simulation centers across the world. As this design simulates an obstructive pulmonary disease, the prototype will help to expand the breadth of situations attainable by SimMan. The prototype was extremely inexpensive to produce. Table 1 shows the cost summary of the entire project. Using one of SimMan's original 11 lungs, a mere $14.25 was spent to purchase the remaining materials. This prototype will not lead to an increase in revenue, yet it will enhance the education Material 1000ml saline bag with tubing4 1.5 oz. Vinyl Flexible Adhesive 10 rubber washers Total Cost $10.00 $2.98 $1.27 $14.25 Table 1. Summary of cost of prototype production. of both medical and nursing students.4 This prototype is quite easy to repair: glue is essentially the only necessary material. Under proper conditions, the prototype should not fail and hence would have a life cycle comparable to an unaltered SimMan lung. If this prototype were to be manufactured, the cost of production would decrease dramatically per output lung. This decrease in cost would be due to several improvements, to be discussed in the Future Directions section. Also, the prototype could be distributed with standard SimMan parts, minimizing its distribution costs. CONCLUSIONS The results from the trials show that the project requirements are all satisfied. The prototype is airtight, proven by the anesthesia machine's bellows. Also, SimMan is capable of working within normal ranges while connected to the prototype lung. Chest compression occurred during the trials, and the prototype did not fail. After readjustment, the prototype proved to fit in the chest cavity without disturbing any other elements. The device was extremely inexpensive to build and quite easily repairable. Most importantly, the device effectively simulates an obstructive pulmonary disease. As the available lung volume decreased, the pressure needed to inflate the lungs increased, as is the case with an obstructive pulmonary disease. Also, the volume of air actually expired by the lungs steadily decreased, a classic sign of progressive obstructive pulmonary disease. 4 http://shopping.netsuite.com/s.nl/c.624515/it.A/id.95/.f 12 As this project mainly pertains to a simulated patient, there are minimal ethical concerns. Still, it can be argued that to be entirely ethical and effective, a simulated patient must be able to simulate all possible patient conditions. Clearly, this is nearly impossible as the human body is extremely complex, but this project does help to minimize any possible ethical problems. This prototype has proven itself to be very safe. It has worked at a wide range of parameters inside SimMan without bursting, tearing or causing any damage to surrounding areas. Also, the prototype should not burst or cause any harm to those manipulating and working with SimMan. Overall, this project has effectively achieved all of its initial requirements. The prototype responds to external control, among the most important goals of this project. In addition, it is a rather simple concept, which will allow for ease in repair and well as reproduction. FUTURE DIRECTIONS There are several improvements that could be made to this prototype to maximize its efficiency. The first is using a longer tube without bulky appendages to hook up to the saline bag. The added length would permit the tubing to extend into the control room during simulations. Also, the lack of extra pieces on the tubing would make the entire apparatus less bulky and allow it to sit in the chest cavity without shifting any other objects. A second improvement would be to find a bag similar in dimension and structure to the saline bag, but without any contents. The main source of cost in the building of the prototype came from the saline bag and its tubing. Hence, without the saline or the gadgets on the tubing, the cost would be much less. 13 The third improvement would involve the point of exit of the saline bag tubing from the lung. This was the most problematic part of the entire building process. Due to the circular hole, it was difficult to find a way to secure it whilst keeping it airtight. In the end, it was sealed with glue and excess vinyl from the original prototype. One option would be to create a plastic grommet with a 6.35mm inner diameter; at the time of this project, there was not one of this size on the market. Another option would be to flip the saline bag inside the lung, so that it exited where the original slit in the lung was made. This would help simplify the sealing process and assist in troubleshooting to find any air leaks. The final improvement would be to find an efficient way to use heat to seal the lung. The vinyl will certainly seal with a heat application, but it will take a specific course of heating as well as a great deal of time. Still, it will be the most efficient way to ensure the lung remains airtight. It will also help to reduce the cost of production. If the prototype is used in a variety of simulation centers, a future goal will be to integrate it into the SimQuest program. The amount of air desired to be injected into the saline bag could be entered directly into the computer and then directly affect the lung. If all of the possible improvements are made, the prototype should become very simple to replicate. production. This would help ensure its marketability and continue to decrease its cost of 14 REFERENCES American Lung Association. "Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet." Diseases. 18 Apr 2007. <http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b= 35020> Barash, Paul, Bruce Cullen, and Robert Stoelting. Clinical Anesthesia. 5th ed. New Haven: Lippincott, Williams & Wilkins, 2005. 18 Apr 2007. <http://www.R2Library.com/marc_ frame.aspx?ResourceID=208> Datex-Ohmeda. "Aestiva/5 MRI." Products and Services: Anesthesia. 15 Apr 2007. <http://www.us.datex-ohmeda.com/products/anesth_aestiva5_MRI.htm> Datex-Ohmeda. "SmartVent Ventilator." Products and Services: Anesthesia. 15 Apr 2007. <http://www.us.datex-ohmeda.com/products/anesth_smartvent_1.htm> James, Francis M, Griselda M. Cooper, and Peter Hutton. Fundamental Principles and Practice of Anaesthesia. Birmingham: Informa Healthcare, 2002. 415. 18 Apr 2007. <http://books.google.com> LexiComp Inc. 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