The good news is that there is increasing recognition that children need to be treated in a humane fashion when having diagnostic and therapeutic procedures outside the operating room environment. The bad news is that some of the practitioners who use sedation and analgesia for these circumstances do not do so in a safe manner. Other good news is that there is increasing recognition by nonsurgeons that anesthesiologists provide an increased measure of safety and convenience for procedures on children in nonstandard settings. The bad news is that the proposed conditions may not be convenient or timely for us. Lastly, the good news is that hospitals, families, and regulatory agencies are also gaining recognition of the important advantages we can bring to diagnostic and therapeutic procedures in new settings. The bad news is that there is a growing discordance between recognition of need for our services and commitment to physical and fiscal support. This talk will focus on some of the trends in providing sedation and analgesia for diagnostic and therapeutic procedures in children, along with suggestions about strategies to ensure the best care.
Do we, as anesthesiologists, really need to become involved in sedation outside our normal environment, the operating rooms? Recent articles have identified some of the problems encountered when sedation or analgesia are provided by practitioners who are also providing the diagnostic or therapeutic procedure. Malviya et al. (1) and Cote et al. (2) have recently published studies attempting to identify important issues related to sedation-related problems. Some of the important issues from their work include the importance of the use of pulse oximetry for detection of hypoxemia, the higher incidence of hypoxemia in children who were classified as ASA class III or IV (3), and the importance of drug overdose as an important cause of permanent patient damage (4). Of interest, Cote et al. found that although drug overdose was identified as a cause of death or permanent disability, there was no clear evidence that any particular drug or method of administration (PO versus IM versus IV) could be implicated as associated with a higher incidence of injury (4). Lastly, the potential for adverse events after the child had been discharged from the facility was identified (4). Although there is no absolute requirement that anesthesiologists either provide direct patient care or assist in the development of appropriate systems, we as a specialty are best trained to be important resources for these issues.
Anesthesiologists are uniquely trained to provide sedative and anesthetic services outside the operating room because of our tradition of focused evaluation of patients, appropriate monitoring, sophisticated understanding of drug choice and administration, and continued care of the patient until the patient is safe for discharge. Because of this systematic and complete approach, anesthesiologists are able to provide safe and superior conditions for a variety of painful or uncomfortable procedures. Our approach can increase throughput for procedures by decreasing lost time secondary to lack of patient cooperation. These advantages have led to increased requests for our routine participation for procedures such as cardiac catheterization, magnetic resonance imaging e-aminations, invasive radiography, and trauma and emergency room care. However, for an anesthesia department to respond to these requests in a timely and appropriate fashion, the department must have a clear plan for providing services in nontraditional environments.
A Rational Approach to Care
When anesthesiologists are asked to provide service outside the operating room, we usually assume that we will be giving general anesthesia and approach the new area with that expectation. Our focus on preanesthetic evaluation and preparation, fasting requirements, medication selection, monitoring, postanesthetic care, and continuous quality management is usually directly applied to care in the new settings, with the assumption that the fundamental aspects of care cannot be compromised when care is provided in distant locations.
The first important challenge in the new setting is to understand the needs and baseline practice of the physicians and other health professionals who have asked for our help. Our comprehensive approach to a patient needing sedation or anesthesia may be foreign to these physicians, especially if they have had little interaction with anesthesiologists. The anesthesia service must clearly introduce our principles and methods when we become involved in new ventures. By establishing protocols, including lines of communication, before actively providing coverage, we can emphasize what we can provide in terms of care and coverage, as well as what we need to provide that care. As other physicians witness how anesthesiologists systematically provide safe and efficient service, there may be a secondary benefit to overall care if these other practitioners eventually incorporate some of these practices into their own.
Experience has demonstrated the need to establish protocols about several aspects of providing anesthetic care outside the operating room. The first step is to survey the needs of the new service or procedure and the setting in which it will occur. After reviewing the proposed procedure and the facilities, several protocols should be developed in conjunction with the physician, nursing, and technical staffs involved. The benefits of careful evaluation, preparation, and development of consensus between all those involved in delivering care is that this preparation will decrease the number of errors, reorganization of efforts, conflict, and patient, family, and physician dissatisfaction with the service (5).
Although each new procedure is different, as well as each institution, there are specific issues that almost always must be addressed whenever anesthetic care is to be delivered to children (6,7). It is important to view the area to gain an understanding of how much room is available for equipment, what equipment can be moved, how easy equipment and patient access will be, whether the door size is adequate, and where patient preparation and recovery will occur. If there is little room to maneuver or gain access to the patient, extraneous equipment must be removed. No matter how spacious an area initially appears, it will feel much more confined once all equipment and personnel are present for the procedure.
Although it is possible to provide sedation and general anesthesia with completely portable equipment, it is more convenient if piped o-ygen, nitrous o-ide, suction, and scavenging are available. There must be adequate electrical outlets and circuits to power the ventilator, monitors, pumps and, if necessary, suction device. If the equipment used for the procedure needs multiple electrical outlets, the institution’s biomedical department should be consulted to investigate whether the remaining outlets are adequate for the anesthesia equipment.
Outlets should be placed to avoid long e-tension cords to minimize the potential for tripping the unsuspecting anesthesiologist. Lighting is often a problem that should be addressed early in the survey of an area because we require abundant lighting to adequately observe, evaluate, and treat a patient.
The table on which the patient will be placed should be e-amined to assess its padding, as well as the capability of the table to be moved or placed in the Trendelenburg position. The anesthesiologist must not only be able to gain access to the patient, but also be able to observe the patient easily. The physician doing the procedure usually will not observe the patient e-cept for the area under study and treatment. Under deep sedation or general anesthesia, the patients cannot protect themselves to the same degree as when awake. The anesthesiologist must be able to position and protect the patient to ensure safety. The arms should not be overfle-ed or e-tended, putting the patient at risk for nerve palsies. Adequate padding must be provided, especially for prolonged procedures. Lastly, if the table is not the same as that used for the induction and emergence from anesthesia, a roller or similar device should be available for moving the occasional obese or heavy patient.
A condition often overlooked is the need to provide temperature compensation for younger patients having prolonged procedures. Most areas do not have the same capability of changing room temperature as an operating room. Constant air conditioning may be necessary to prevent overheating of equipment such as radiology machines. Patient protective coverings, heating blankets and lights, heated humidifiers, or fluid warmers may be needed to prevent hypothermia. The use of portable forced-air warming blankets is particularly useful for maintaining a stable temperature in a nonintrusive fashion.
A means of outside communication (telephone or intercom) should be readily available in the area in case help or additional equipment or supplies are needed. Those responsible for providing anesthesia equipment and supplies should be familiar with the area in which the procedure is being performed so that additional supplies can be brought to the area without disrupting the procedure.
One lesson that many anesthesia departments have learned the hard way is that equipment needs should be established and provided before agreeing to work in a new setting. If anesthesia services are frequently required in a given location, it is preferable to have anesthesia equipment permanently based in the area. Disposable equipment and drugs can either be brought for each case or routinely stocked on site. Because the e-pense for this arrangement is considerable, discussions with those buying the equipment—usually the institution—must stress that the equipment will be used frequently enough to make the e-penditure cost-effective. Equipment and supplies left on-site must be kept in secure and locked facilities when not in use to prevent theft or abuse, as well as guarantee availability if there is emergency use of the area. Although it is reasonable to keep some drugs in a locked cabinet, it is prudent to store controlled substances and those that require refrigeration in the main anesthesia supply area and bring them as needed.
If an anesthesia machine is brought to the site, there is a potential hazard for top-heavy machines to either tip over or collide with personnel, walls, and other equipment. Wheels can easily be caught in gaps between the elevator and the floor and can jump when they run over e-pansion joints in the floor. In our institution, we modified our standard anesthesia machines that are used outside the operating room by widening the wheelbase and installing larger wheels to increase stability and control. However, our e-perience has been that it is better to purchase additional machines that are dedicated to a site where we provide repeated service and avoid transporting anesthesia machines whenever possible.
Adequate facilities for patient and family should be provided. There should be adequate facilities for privacy for changing and waiting with family members, as well as a conference or e-amination area to discuss matters with the family. During the procedure, the child should not be e-posed to other procedures or traffic, in the same manner as in the operating room. Lastly, parents or others who are waiting during the procedure should be informed about nearby telephones, restrooms, and food and water resources.
After the site survey has been finished, the anesthesia service should establish protocols with the requesting service about patient selection and preparation. Patients having anesthesia outside the operating room environment must receive the same evaluation and preparation as those coming to the operating room. Is the patient going to have the procedure and anesthetic on an outpatient basis? Are only healthy patients having this procedure performed or do the patients have significant underlying medical problems that necessitate the procedure? If the patient has serious medical problems, who is responsible for ensuring that the child is in the best possible condition before admission? Does the anesthesia department have special requirements that the managing service should know about, such as mandatory overnight admission and monitoring of some former preterm infants?
These are comple- questions that should be fully e-plored. Many physicians, such as radiologists, usually are not involved in determining the overall medical status of their patients. Preanesthetic evaluation by the child’s pediatrician or other physician may be an appropriate routine to guarantee that the child is in the best possible general medical condition before the procedure. In many institutions, a preprocedure history and physical e-amination, in addition to a separate anesthesiologist’s evaluation, is needed before general anesthesia is administered. The anesthesia and managing services must decide who is qualified and responsible for performing this evaluation. In our own institution, medical staff bylaws were changed to allow a single history and physical e-amination to be used for noninvasive diagnostic radiologic procedures under general anesthesia, and the physician (nonradiologist) requesting the procedure provides a brief, appropriate note about the patient’s status. If the patient’s status is clear on the basis of this note, the anesthesia service provides the single history and physical e-amination because it is the anesthesia service that will use this information in patient management. Complicating this process is the increased demand by insurance carriers that patients have procedures on an outpatient basis if at all possible. There must be a concerted effort by the anesthesia service to educate the managing service about the need for proper preparation.
A simple solution to many of these challenges has been used in several institutions. Patients having general anesthesia for procedures outside the operating room are admitted through the operating room’s ambulatory care area. The nursing staff includes these patients in their normal routine for surgical candidates. This can include instructing the family before the day of the procedure, calling the night before to check on the child’s status, reinforcing fasting instructions, and confirming time of arrival for the day of the procedure. The advantage of this approach is that this nursing staff is usually very adept at detecting problems and communicating with the appropriate service before the day of the procedure. If further testing or consultation is needed, this is arranged before the patient arrives at the institution. These functions can also be served by staff at each area outside the operating room as long as they understand the need to communicate with both the managing and the anesthesia services.
The issue of providing care outside the operating room environment is complicated by finding the personnel to provide the anesthetic service at the time required. As the amount of time committed and number of sites covered increases, there is an increased burden on the anesthesia service. Services that desire and use coverage on a regular basis are incorporated into the normal operating room weekly schedule, often establishing a routine of coverage each week or every other week. This coverage is monitored and altered, as usage demands, with the expectation that if a day of coverage is offered, enough cases will be booked to fill the allowed time. Experience has demonstrated that some services increase their use of anesthesia services after they determine that throughput is increased by our presence. Other services do not provide the volume they anticipated. The governing principle is that routine coverage is provided only if there is continuing volume. For coverage on nonscheduled days, the requesting services understand that the department will provide personnel, but it may be at the end of the workday. Emergency cases are judged and covered as other emergencies in the institution.
What about the request to run up to the clinic and give just a little, or light, anesthesia for a short procedure? One of the important educational aspects of providing care outside the operating room is to communicate to our colleagues the nature, risks, and benefits of providing sedative and anesthesia services. Although it is good medicine and good politics to be available to help provide humane services throughout the institution, those requesting the service must understand the requirements of the anesthesia service. This should be balanced against the possibilities that either adequate sedation or analgesia may not be provided if we are not available or that the requesting service may provide sedation or analgesia on their own without the same safeguards that the anesthesia service feel are in the child’s best interest.
When anesthesia is administered in a nontraditional setting, the same rules about preanesthetic fasting apply (8,9). The criteria for adequate preanesthetic fasting have changed dramatically for pediatric patients in the last few years (10,11). Because most pediatric anesthesia departments have adopted a policy of allowing clear liquids on the day of anesthesia up until 2–3 h before the induction or administration of sedation (12), with no restriction on the amount of clear liquids, these guidelines should be shared with the new services. However, even with this liberal policy, there is a problem with some radiologic procedures. To obtain satisfactory abdominal computerized tomography examinations, as many as half the patients must be sedated and drink significant quantities of oral contrast agents (13). If the sedated patient has lost some ability to protect the airway, there is a risk of aspiration. Obviously, the more profound the sedation, the greater the risk of loss of reflexes. Should these patients all have their airway secured before receiving oral contrast materials? There is a lack of evidence in the literature that aspiration has been a problem in this setting. However, the physician in charge of the sedation must closely monitor the patient, aware of the risks of sedation and a full stomach.
The anesthesiologist must be aware that the managing service physician may have little experience with the normal course of a child’s recovery from anesthesia. If there is no residual problem related to the procedure, the determining factor in discharging a patient from a recovery area or the institution is often best made by the anesthesiologist. If the anesthesiologist does not take the responsibility for discharge, there should be a clear mechanism for both determining discharge suitability and responding to problems. Protocols should be established to guarantee that the family is given instructions about postprocedure and postanesthetic care. They should be given a telephone number that they can call at any time if they have questions and must be clearly instructed under which conditions they should immediately bring the child back to the institution for evaluation. If the normal procedure for surgical patients is for a follow-up telephone call to be made the following day, the same should be accomplished for these patients. Also, anesthetics given outside the operating room should be the object of the same continuing quality assurance program that is used for surgical procedures.
Sedation by Nonanesthesiologists
Anesthesia departments are not usually willing or able to provide all care needed for all patients receiving sedation in an institution. However, they can contribute to the safety of pediatric sedation by participating in the development of institutional guidelines that can be followed by different departments. As new, potent drugs, such as propofol and remifentanil (14,15), which have traditionally been reserved for use by anesthesiologists, start being used in new settings, it is important that anesthesiologists participate in establishing institutional guidelines.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has published rules for the development of guidelines within institutions they accredit, stating that when medications are given that can result in loss of consciousness, there should be mechanisms or processes specified for evaluating and monitoring these activities, as well as establishing guidelines for safe administration (16). The director of organized anesthesia services in that institution has a responsibility to participate with services that administer these drugs in developing the process of establishing guidelines, but it is the responsibility of the department or service providing the sedation that has ultimate responsibility for both the guidelines and the care delivered. In recent comments, the JCAHO noted that although no JCAHO standard directly addresses “conscious” sedation, standards that apply when sedation is used include those about informed consent, staff competence, data collection for processes that involve risk, and procedures that place patients at risk, among others (17). The JCAHO clearly states that each institution should develop criteria for competence of practitioners who desire to administer sedation in their institution. The JCAHO guidelines have been revised for 2001 and will be discussed.
What criteria should be used to identify competence and proper practice of sedation? Different organizations (18–22) have developed standards and guidelines to encourage safe care. These standards and guidelines are usually concerned with evaluation, monitoring, and general care instead of “cookbook” formulas for specific drugs. The American Society of Anesthesiologists (ASA) has published standards for basic intraoperative care (23), as well as for sedation and analgesia by nonanesthesiologists (21). The guidelines for sedation of children produced by the American Academy of Pediatrics (AAP) (19) and revised in 1992 have been particularly popular and have become the basis for institutional guidelines in several instances. Why so many different guidelines instead of just one set that everyone can agree to (24) ? There are substantive differences between the guidelines about the degree of monitoring required for specific types and levels of sedation. The AAP and ASA guidelines closely mirror the general approach to sedation that anesthesiologists traditionally take.
The AAP and ASA guidelines (19,20) discuss the distinction between conscious sedation and deep sedation, with conscious sedation being a state of depressed consciousness in which the child retains a patent airway and protective reflexes and is arousable by verbal command or physical stimulation. Deep sedation is any state from which the child is not easily aroused or does not maintain an adequate airway, but the distinction is a difficult one to make because the sedative state is often fluid, moving from one level of depression to another. In addition, there is now a distinction being made between sedation and sedation with analgesia, a state induced by use of more than one class of drug.
The general guidelines for both conscious and deep sedation have several points in common. First, equipment requirements include (on-site and available) a positive-pressure o-ygen delivery system that can administer at least 90 o-ygen for at least 60 min. An emergency kit must be available, as well as monitors and a suction device. Second, documentation for the sedation should include a pre-sedation health evaluation, informed consent, records of medication given, vital signs, recovery parameters, and instructions at discharge to the responsible person. Third, for conscious sedation, there must be a person in addition to the practitioner providing the procedure, to monitor the child. Monitoring should include continuous measurement of oxygen saturation, heart rate, intermittent respiratory rate, and blood pressure. For deep sedation, the monitoring personnel should have that monitoring as their only responsibility. The capability for electrocardiogram monitoring and placement of vascular access must be available. Of interest, electrocardiogram monitoring is exempted from monitoring requirements in magnetic resonance imaging because of potential thermal injury. Also, with deeper levels of sedation, capnography can be very useful in detecting hypoventilation and airway obstruction. Lastly, specific discharge criteria should be documented before the child leaves the treatment area or facility.
The ASA and AAP guidelines are provided as suggestions for care, not absolute standards. However, they are an attempt to provide a framework to guide sedation by nonanesthesiologists. As each anesthesia department participates in developing its own institution’s parameters, these guidelines may be of help. The additional support that each anesthesia department provides in terms of coverage of procedures requiring sedation, though not necessarily anesthesia, should be clarified. This will enable other services to determine their needs for development of sedation mechanisms.
Although providing anesthesia outside the operating room is an exciting and challenging enterprise, there are multiple challenges that must be addressed in a proactive fashion to ensure effective and efficient care. However, meeting these challenges can increase the level of safety, convenience, and comfort provided to all children.
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