The Nurse's Role in Delivery of Radioisotope for Ictal SPECT Scan.
Epilepsy is one of the most prevalent neurologic conditions today. Approximately 0.5-1% of the population, or 2.5 million people in the United States, have epilepsy. Thirty percent of these are under the age of 18 years. However, seizures are also increasingly associated with the elderly. There are about 125,000 newly diagnosed cases of epilepsy each year. Epilepsy related costs are estimated at over $3.9 billion per year. This includes one-third in direct medical costs and two-thirds in the indirect costs of lost productivity. Approximately 65% of children with epilepsy have special needs. In addition, mortality rates in people with epilepsy are 2-3 times higher than in the general population. It is important to the quality of people's lives and the economy as a whole that progress is made in the treatment and relief of a condition that has such far-reaching implications.
The ictal single photon emission computed tomography (SPECT) scan is used as a diagnostic tool for the surgical treatment of epilepsy patients. Many inpatient epilepsy programs are not utilizing the SPECT scan on a widespread basis largely due to the logistics of administration of the isotope and the unpredictable nature of seizures. This article describes the successful ictal SPECT program at MCG, a model for other epilepsy centers to follow.
A seizure is defined as a sudden abnormal discharge of cerebral neurons. It is characterized by brief attacks of altered consciousness, motor activity or sensory phenomena perceived by the patient and/or observers. Seizures can occur for a variety of reasons that do not constitute a diagnosis of epilepsy. These include electrolyte or metabolic imbalance, alcohol or other drug withdrawal, adverse response to certain medications, hypoxia, uncontrolled diabetes or toxemia of pregnancy. These are classified as provoked or symptomatic seizures. If these events are isolated and do not recur, these persons are not considered to have epilepsy. Epilepsy is the tendency to have recurrent unprovoked seizures. An unprovoked seizure can have a known cause or underlying condition, or may be ideopathic. The major causes of epilepsy include head trauma, birth injury, central nervous system (CNS) infection, brain tumor and vascular disease. However, over half of epilepsies have an unknown etiology. Approximately 60% of people with complex partial seizures can be well controlled on medication, while 40% become refractory to medical treatment.[11,23] For many epilepsy patients, surgical treatment is a viable alternative. People with intractable epilepsy make up the majority of the patient population seen in epilepsy centers. In patients with intractable epilepsy, the goal is to locate the area of the brain where the seizure begins. Then, in many instances, the abnormal focus of brain cells can be surgically removed.
Monitoring for Surgical Evaluation
A patient admitted to the Epilepsy Monitoring Unit for presurgical evaluation is a person who has a definite diagnosis of epilepsy and has poor seizure control with several antiepileptic drug (AED) trials. This patient is considering surgery as a treatment for their epilepsy. This is an elective admission and is called Phase I (one) evaluation for surgery. Phase I testing involves noninvasive monitoring with scalp electrodes, and includes a barrage of tests geared toward localization of the seizure onset, or focus. Each Phase I patient will undergo a special epilepsy protocol magnetic resonance imaging (MRI) scan, sphenoidal electrode placement, tapering to discontinuation of AEDs, neuropsychological testing, ictal/interictal SPECT scan and arteriogram with intracarotid sodium amobarbital test. A minimum of three typical seizures recorded on simultaneous video/EEG monitoring are desired for study by the physicians. The identification of the seizure focus remains a significant diagnostic challenge, especially for extratemporal lobe epilepsy.
The ictal SPECT study is done on nearly all Phase I patients in our program. Those patients on whom the test was not done did not have seizures during the hours that the ictal SPECT test was available. The scan is available Monday through Friday from 7:30 am to 3:30 pm. Cost and personnel constraints currently limit the hours that ictal SPECT can be performed. Also, if a patient is disconnected from EEG monitoring for any reason, the injection is not performed until the next seizure that is recorded occurs, so the scan can be correlated with the EEG.
Value of Ictal SPECT
The ictal SPECT scan is a perfusion study which images regional cerebral blood flow (rCBF). It represents a "snapshot" of the rCBF at the time of injection. During a seizure, there is increased blood flow to the part of the brain that is involved in the seizure. The radioactive agent rapidly crosses the blood brain barrier and concentrates in the area of the brain with the highest blood flow, which correlates with the seizure activity. Functional imaging, such as SPECT, is a promising tool because it reflects the actual location of seizure activity. Interictal (between seizure) studies are of limited value, localizing the seizure focus in 60-80% of cases, while the accuracy of ictal (during the seizure) SPECT in localizing temporal lobe seizures, up to 97%, is now well established.[19,20] In temporal lobe seizures, which are the easiest to localize and have the highest percent of successful surgery, ictal SPECT confirms the location of the seizure focus along with the EEG and MRI. In patients with negative MRI scans, ictal SPECT can provide seizure focus lateralization and localization. Extratemporal epilepsies, that is, seizures in the frontal, parietal or occipital lobe, are much more difficult to localize. Ictal SPECT provides one of the best currently available noninvasive methods for finding the seizure focus in extratemporal epilepsies. In addition, ictal SPECT is a valuable tool, combined with EEG, in identifying optimal placement of subdural grids when invasive monitoring is necessary.
While MRI and CT scans can identify structural lesions, functional neuro-imaging studies such as SPECT and Positron Emission Tomography (PET) provide further information in the evaluation for epilepsy surgery by demonstrating cerebral perfusion or metabolism. SPECT studies are available at most hospitals with a nuclear radiology department and use conventional and readily available equipment and radiopharmaceuticals. SPECT studies are substantially less costly than PET,[11,14] and most importantly, ictal studies can be performed.
The superior accuracy of ictal SPECT studies in localizing seizure focus is well established. The ictal SPECT scan in Figure 1 shows an area of increased uptake (the "hot" spot) in the temporal region, which is the area of seizure activity onset. Extratemporal seizures are usually quite brief. Therefore, it is much more challenging to achieve a true ictal scan. However, the high diagnostic value justifies the special organizational effort needed to obtain such studies. In these cases, the nurse reviews the videotapes of the patient with the physician for seizure characterization and pattern of occurrence prior to performing the ictal injection. The nurse then sits at the patient's bedside, often with the syringe already inserted into the injection port, waiting for the seizure to occur. Injection times range from 2-10 seconds after seizure onset when the nurse is sitting at the bedside. Excellent scans have been obtained with this protocol, which is especially useful with children.
[Figure 1 ILLUSTRATION OMITTED]
Barriers to Onsite Ictal SPECT Program
There are several barriers to onsite ictal SPECT injection. The Nuclear Regulatory Commission (NRC) of the United States regulates the use of all radioactive substances. However, if a particular state wishes to manage and oversee it's facilities' use of radioactive materials and agrees to follow all of the federal regulations, the state is called an "agreement state" and will be allowed to administer all programs on the state level. A facility in a state that does not agree to the federal mandate ("nonagreement" state) falls under the direct supervision of the NRC. Institutions wanting to use radioactive materials must apply for a license. The manner in which the application for license is worded can be very specific, such as limiting radiation usage to certain rooms in the building, specific procedures and personnel, etc, or it can be broad with no such stated limits. With a limited license, an institution may have to get permission for any change in procedure or personnel. With a broad license, the institution is allowed to make such procedural changes on their own as long as they are in compliance with regulations. The governing body must have confidence in the institution that adequate radiation safety personnel are available to administer and oversee the programs in place.
Georgia is an agreement state, and the Medical College of Georgia operates under a broad license with a well-trained experienced staff of Radiation Safety officers under the direction of a Radiation Safety Committee. Our license allows us to use radioactive isotopes anywhere on campus. The regulations and maximum exposure limits established by MCG are more stringent than state regulations (1/10th) to allow an even greater margin of safety for patients as well as staff. Our program is audited by Radiation Safety every 3 months. Quality assurance data shows that radioisotope injection can safely be performed outside a Nuclear Medicine Department. Most large medical centers function under a broad license. So if your Neurology Department has had difficulty getting an ictal SPECT program off the ground, it may be necessary to investigate the rules under which your hospital functions related to radiation usage and safety.
Nurses may fear handling and exposure to radioactive isotopes. In 1992, Jankowski stated that nurses' fears about exposure to radiation can be greatly reduced by education. Federal and state rules and regulations are the basis for hospital policies regarding radiation safety for nurses. The goal of radiation safety officers and nursing administration is ALARA: that radiation exposure to staff nurses will be As Low As Reasonably Achievable. This is accomplished using the three principles of time, distance and shielding to reduce radiation exposure to staff and patients.
In overcoming nurses' fears of handling the radioactive materials, the first point to emphasize is that Technetium (Tc99m), properly shielded and handled, is a safe radioisotope. It has been used since 1966 and is now the main imaging isotope used in the US. Tc99m emits low energy photons, which are not deposited in the body. The scanner detects tracer uptake in the brain and an image is produced. The imaging dose to the patient is low, and no tissue damage from ionization results. Technetium's short half-life of six hours means that it will fully decay to background in 60 hours, or 10 half-lives. A patient can have a repeat injection for interictal or ictal SPECT if needed within 36-48 hours after the initial injection. Also any contamination of the environment has dissipated in 60 hours.
Studies have been done concerning the radiation exposure of staff members who handle radioisotopes. Results showed a significant downward trend in amount of exposure in spite of a stable or increased work load per employee. Safety measures, staff selection and training are cited as reasons for reduced exposure. A radiation film badge worn on the shirt and a dosmeter ring worn at the base of the middle finger, facing the palm, have been shown to accurately measure the employee's radiation exposure. Several nurses in the Epilepsy Monitoring Unit are trained to allow rotation of the duties. Each nurse is assigned to ictal SPECT duty approximately 1-2 times per week for an eight hour shift. Special consideration is given to pregnant nurses hospital-wide. In our unit a pregnant nurse was not required to perform the duty of ictal SPECT injection nurse. In addition, a fetal monitoring badge was issued, and no radiation above controls was noted for the nine months of pregnancy.
A radiopharmaceutical is designed specifically for the target organ. The radioisotope is combined with the pharmaceutical agent, which carries the isotope to the target organ. When used for diagnostic purposes, a radiopharmaceutical elicits no physiological response from the patient. The radiopharmaceutical is rapidly taken up by the target organ and fixed for a sufficient period of time to allow scanning. Also, if clearance from surrounding tissue is rapid, the emissions ratio of target area to surrounding tissue is increased, thereby improving the scan.
Hexamethylpropylene amine oxime (HMPAO), or Ceretec[R], was the first radio-pharmaceutical used routinely for ictac SPECTs. HMPAO gained Food and Drug Administration (FDA) approval in 1990; MCG begain doing brain SPECT scans for epileptic focus localization in 1993. Ceretec[R] is unstable when mixed, allowing a 30 minute window for use. Ethyl cysteinate dimer (ECD), or Neurolite[R], also called bicisate, was approved for use in the US in 1995. It had already been in use in Europe with studies published from Germany and Hungary. The advantage of ECD over HMPAO is it's high in vitro stability. It is stable for 6 hours after mixing with the Tc99m, which allows it to be mixed in advance and be readily available when a spontaneous seizure occurs. High initial cerebral extraction and very slow clearance from the brain makes it an excellent ligand for brain SPECT, allowing the scan to be performed from 10 minutes to 6 hours post injection. ECD is primarily excreted by the kidneys. Fifty percent of the injected dose is excreted within 2 hours after injection. There are no known contraindications to the use of Tc99m-ECD in patients. No side effects to the patient have been recorded either during or after radiotracer administration using Ceretec[R] or Neurolite[R]. In 1996, HMPAO became available stabilized with methylene blue, which allows it to be used up to 4 hours after mixing.
Development of Ictal SPECT
SPECT imaging of the brain was developed in Europe and Australia in the early 1980s for measuring cerebral blood flow in cerebral vascular disease. At the time [Iodine.sup.123] with iodoamphetamine as the radiopharmaceutical agent was used for this purpose. The use of Technetium 99m with HMPAO in the mid-1980s led to other studies of brain function including patients with stroke, arteriovenous malformation (AVM), transient ischemic attacks (TIAs), hemorrhage, dementia and seizures. A group of neurologists in Melbourne, Australia were pioneers in the study of ictal, interictal and postictal SPECT and published several articles in journals years before HMPAO was approved by the FDA here in the United States. Dr. Berkovic of Austin Hospital in Melbourne came to Neurology meetings in the United States to discuss the procedure and to show scans. HMPAO, the first widely used radiopharmaceutical for SPECT scans, is unstable after it is reconstituted in the vial. Therefore, it cannot be mixed ahead of time to wait for a seizure to occur. As a result, most early studies were interictal or post-ictal. Newton, et al developed a multidisciplinary method for preparation of the radioisotope within 30 seconds. This allowed them to achieve 68% of injections (50 out of 78 patients injected) during the seizure. Attending physicians and fellows performed the reconstitution of HMPAO and the injection. They conclude that medicine was on the threshold of an "exciting new era in the functional imaging of human epilepsy" (p. 670).
When we began performing SPECT studies for seizure localization at MCG, our initial procedure was to notify the Nuclear Radiology Department when a patient had a seizure, whereupon the technologist came to the Epilepsy Monitoring Unit to inject the radioisotope, usually within 30 minutes. Scans were of no diagnostic value with this method. The next procedure we tried was to have the Nuclear Medicine Tech wait in the EMU for a seizure to occur. He/she would mix the radiopharmaceutical (HMPAO) with the radioisotope, Tc99m, upon announcement from the nurse that a seizure was occurring, then inject. Scans were still poor, and this method took a technologist out of his department for an extended period of time. The need was identified to develop a procedure that would provide on-site injection immediately upon seizure identification, utilizing available personnel. Neurologists met with Nuclear Radiology, Radiation Safety, Risk Management and Nursing Directors to determine the feasibility of nurses performing the injection. Since nurses are already in the unit caring for patients, have the knowledge base to prepare and inject the radioisotope, and to identify the occurrence of a seizure, it seemed only natural that this was the way to proceed.
MCG's Nuclear Radiology Department set up a small satellite in the medicine room of the monitoring unit to handle and store the radioisotope during the day. This included a dose calibrator, lead-lined containers for disposal of contaminated supplies such as syringes and IV tubing, a radiation survey meter (Geiger counter) and lead shields. Ten. hours of training was required of a team of select nurses chosen to prepare and administer the radiopharmaceutical. The training included orientation to nuclear medicine, basic chemistry of radioactive materials, and mixing and handling of the isotope with the ligand (radiopharmaceutical) taught by the radiopharmacist. The radiation safety officer explained basic radiation safety practices and dosimetry, and provided each nurse with a radiation badge and ring. An annual update class is also required of each nurse on the team.
The Nurses' Role
In 1994, since HMPAO could not be mixed in advance, the procedure we performed when a patient had a seizure was as follows:
* mix the isotope (Tc99m) with the vial of HMPAO (package insert states 2 minutes)
* look at the dosing spreadsheet, locate the time and the number of mls needed for the target dose
* withdraw into the syringe the required number of mls
* assay the dose in the calibrator
* place the syringe in the syringe shield
* run to the patient's room, inject and flush with saline
Unless the seizure was a long one, it was difficult to accomplish the injection before the seizure was over. After about 6 months, the procedure was refined for the purpose of shortening injection times because scans had not been clinically useful. Shortening the mixing time to 10 seconds still allowed enough radioactive tagging of the Ceretec[R] to result in good scans. A second nurse would get the IV port free and crimp the tubing in readiness for the mixing nurse to inject. These two acts helped reduce our time from seizure onset to injection by 42%, which is illustrated in Figure 2.
[Figure 2 ILLUSTRATION OMITTED]
In 1995, after ECD was ap, proved, we used it sporadically at first, then exclusively from mid 1995 to the present. When Neurolite[R] is used, the nurse no longer has to mix the ligand with technetium, since it is done by the radiopharmacist in the morning and delivered to the EMU already mixed. The dose is accompanied by a spreadsheet (Figure 3) with the time, target dose and acceptable dose range [+ or -] 10%. The nurses' responsibility is to assay and record the dosage calibration every 30 minutes, while watching the monitors for seizure onset. Each morning at 6:00 am the intravenous (IV) fluid is set up with Normal Saline running at 50cc/hr via Control-a-Flow[R]. The nurse assigned to ictal SPECT duty is responsible for checking the entire set-up for accuracy and the tightness of all connections. An absorbent plastic-backed pad is placed under the patient's arm and W tubing.
[Figure 3 ILLUSTRATION OMITTED]
Important factors required in a program for the achievement of on-site ictal SPECT injection include:
* an W line established prior to the onset of the seizure to permit rapid administration
* video/EEG monitoring to ensure that injection is given during the seizure
* availability of the radiopharmaceutical at the patient's bedside or adjacent area
* personnel trained in the administration of radiopharmaceuticals to inject the radioisotope during the seizure
In our Epilepsy Monitoring Unit designated staff nurses are trained to respond quickly and efficiently when a seizure occurs, and to inject the isotope rapidly and safely. Our Nuclear Medicine Department is flexible in scanning patients as soon as possible after the injection and very supportive of the program as a whole. Their personnel handle procurement and mixing of the technetium, perform all quality controls, write the policies and procedures and maintain record-keeping for the program.
Safety measures for the patient include a Beta-HCG qualitative serum pregnancy test for all females of childbearing age, use of a 20 gauge IV catheter to reduce incidence of infiltration during rapid IV injection of the radioisotope, an absorbent plastic-backed pad under the injection site to protect the patient and environment and frequent calibration of the dose to ensure it is within the target range for adequate scanning.
Safety measures for the nursing staff members include the wearing of protective lab jacket and gloves, lead lined containers for storage and disposal of syringes and W tubing, syringe shields and wearing of radiation dosemeter (film) badges and rings. The use of tungsten syringe shields reduces radiation dosage to the hands. This is especially important when a nurse is sitting at the bedside of a patient who has a very brief seizure. However, the majority of the time, the syringe with syringe shield is contained within a portable lead-lined box which is kept at the nurses' station by the responsible nurse who is watching the EEG monitors (Fig 4). The nurse monitors from 2-4 patients, waiting to inject the radioisotope if a seizure occurs. Staff ensures that there is an unobstructed path to the patient's bedside from the monitoring station to prevent tripping or falling by the nurse in the rush to inject the isotope as soon as possible after seizure onset. Injection would not be performed if the seizure is over when the nurse arrives.
[Figure 4 ILLUSTRATION OMITTED]
After the patient leaves the unit to go for the scan, usually 15-90 minutes post injection, a nurse checks the room with a radiation survey instrument. If radioactivity is detected, the area of contamination must be precisely located. The contamination is contained in the immediate area by restricting traffic in the room. If a droplet is on the carpet, a lead shield will be placed over the site, marked with yellow radioactive alert tape and remains in place for three days. If skin is contaminated, it is washed profusely with soap and water or Radiacwash[R], which is effective in reducing or eliminating radioactivity quickly. If contaminated items are removable, such as clothing or bed linen, they are placed in the lead lined bucket in the EMU. If an item is too large for the bucket, such as the padded side rail covers from the bed, it will be taken to the Nuclear Medicine Department for three days. The nuclear pharmacist is notified of any contamination, and if the spill is large, the Radiation Safety Officer will be notified. After three days, the contaminated items are rechecked with the radiation survey instrument, removed from shielding and returned to use.
We have performed a total of 320 SPECT injections from January 1994 to June 1998 and have experienced only 6 incidents, or 2% of cases. Two of these were W infiltrates in which the radiation dose remained in the patient's arm and no scan could be performed. There is no tissue damage from infiltration of Neurolite[R]. The other four incidents involved problems with the W tubing and resulted in radioactive spills contaminating the environment, staff members or patient. These incidents occurred following a hospital-wide change to new IV tubing. We were very concerned about the incidents, and took steps to solve the problems we encountered. Nurses conferred with physicians, nuclear radiology and the sales representative to troubleshoot our IV setup and to make changes.
Members of the nursing staff developed several improvements to ensure the success of the program. The new IV setup has eliminated incidents since its implementation. At all joints, the W tubing is connected hub-to-hub using luer-loks rather than secondary attachments, including at the heplock extension on the patient's arm. A Y-site with back-check vanes had to be special-ordered for our use. This eliminates flow of the radioisotope back up the IV tubing and also the necessity of another person having to crimp the tubing. Another plain Y-site is connected to the first one, which is used for the hub-to-hub attachment of the flush syringe and the injection port. A diagram of the IV tubing set-up is provided in Figure 5. This setup has been a major factor in the continued success of our protocol for onsite ictal SPECT injection.
[Figure 5 ILLUSTRATION OMITTED]
The timing of the isotope injection in relation to the onset of the seizure is crucial for reliable localization of seizure focus. Our data show that the time between seizure onset and injection was reduced by 47% in the first six months of ECD use compared to using HMPAO. In the past two and one-half years, we have performed 155 ictal injections, averaging 67 injections per year. Our average injection time was reduced from 28 to 19 seconds during this period (Fig 2). The procedure has been performed by seven different nurses, included in the average. Fifteen injection times were 15 seconds or less, and in only 3 of these was the nurse at the bedside. Twenty-four injections occurred 16-25 seconds after seizure onset, and only six were 50 seconds or greater. Variations in injection time are dependent on seizure onset identification, travel to the patient's bedside and ability to stabilize the IV port during seizure activity to allow injection.
The later the injection is made after seizure onset, the less useful are the results of the scan in determining seizure focus. For example, if a patient has a complex partial seizure that secondarily generalizes, injection during the generalized portion of the seizure results in a scan with diffuse radioisotope uptake, with no localized "hot spot," which is usually not diagnostically significant. It is very important for the injection of radioisotope to occur as close to the onset of the seizure as possible before it spreads to other parts of the brain, so the location of the onset can be visually determined with the SPECT scan.
Success of the Multidisciplinary Team Effort
At MCG, there is a weekly Epilepsy Surgery Conference in which cases are presented of patients who have completed the Phase I testing. At this time, physicians and nurses from the departments of neurology, neurosurgery, radiology and neuropsychology review all the test results, and recommendations are made for further invasive monitoring, ablative or palliative surgery, or for alternative treatments if the patient is not a surgical candidate.
All patients remain on AEDs at least one year after surgery. If they are seizure-free during this period, they can decide, along with the physician, to begin tapering off medications. About two-thirds of patients who are seizure-free for one year after surgery will remain so after AEDs are discontinued. The other one-third can be seizure-free if they continue on medications. Seizure-free patients experience a vast improvement in quality of life. Most are able to drive, find employment and lead productive lives.
Epilepsy surgery is an accepted and often effective treatment for seizures which are intractable to other medical therapies. Surgical intervention in epilepsy, although still under-utilized, is presently well accepted and performed world-wide with increasing frequency. The evaluation to determine whether one is a candidate for this treatment is undertaken in a careful step-by-step fashion and requires a good deal of commitment on the part of both the patient and the physician. If seizures start in one part of the brain, ie, are focal in onset, then that area can be identified through testing. If it can be determined that the seizure focus can be removed without producing a medical or neurological complication, then surgical treatment can be considered. Since ictal SPECT scanning is a major factor in seizure localization in many patients, we encourage its use in centers performing or considering this type of surgery.
The protocol described in this article was developed for the purpose of obtaining diagnostically significant SPECT scans for seizure focus localization. It has been demonstrated that this is a viable role for nurses in a seizure monitoring unit to perform. The benefit to the patient through increasingly successful surgeries resulting in better quality of life is evident. The excellent performance of our nurses in reducing the time between seizure onset and injection is attributed to dedication, practice and experience with the large volume of injections we do, as well as following the protocol that has been developed.
The author would like to thank Drs. Don King and Yong Park for their assistance with research, manuscript review and guidance on clinical issues; James H. Corley, MS, RPh, nuclear pharmacist, for his daily support of the ictal SPECT program, assistance with research and manuscript review; Jean H. Yoder, BS, CNMT, for obtaining the sample scan; Boaz Leung, RN, for artistic assistance with the IV setup diagram; Evelyn Coleman, EEG Technologist, for assistance in obtaining and interpreting EEGs; and Harley Jones, RN, for manuscript review and encouragement throughout the project.
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Questions or comments about this article may be directed to: Nancy A. Huntington, RN, BSN, Medical College of Georgia Hospital and Clinics, 1120 15th St., Augusta, GA 30912. She is Senior Staff Nurse in the Epilepsy Monitoring Unit/Operating Room.
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|Author:||Huntington, Nancy A.|
|Publication:||Journal of Neuroscience Nursing|
|Date:||Aug 1, 1999|
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