**2. Background**

Acute respiratory failure—regardless of the etiology—remains a complex and difficult problem to treat. Management focuses on treating the primary problem and allowing lung healing via lung protective ventilation strategies, while maintaining adequate oxygenation and ventilation [3]. Unfortunately, morbidity and mortality remain high in patients with severe lung injury, despite implementing standard lung protective strategies. Even for those patients who survive, quality of life can be severely impacted for many years after their initial illness [4]. Acute cardiac failure, or cardiogenic shock, also presents a difficult clinical problem for which even contemporary outcomes are less than ideal. While the most common cause of cardiogenic shock remains pump failure after an acute myocardial infarction, other mechanical problems such as acute papillary rupture (with acute mitral regurgitation), ventricular septal rupture, and myocarditis [5] must be considered [6]. While the use of ECMO for either acute respiratory failure or cardiogenic shock (or often a combination of both) is well-described, in part due to more comprehensive reviews of these topics elsewhere in this text, their incidence and challenges—regardless of the circumstances—serve as a foundation for why there is a substantial interest in developing and growing ECMO programs.

There is growing evidence to support the role of ECMO in the management of these very difficult problems. ECMO has been shown to be an important tool in the armamentarium of any program that serves as a tertiary or referral center for complex cardio-pulmonary pathologies. In fact, excluding the survival benefit that has been demonstrated in patients who are supported with ECMO, there is also growing evidence to suggest that overall outcomes of patients with Adult Respiratory Distress Syndrome (ARDS) or cardiogenic shock treated at "ECMO Program Centers" are better regardless of whether they are treated with ECMO. In other words, the multi-disciplinary and administrative commitment to take care of patients (both adults and children) with complex and difficult cardiac and pulmonary problems can lead to improved outcomes independent of the actual use of ECMO [7–10].

Two randomized clinical trials in patients with severe ARDS support the implementation and increased utilization of ECMO therapy [11, 12]. These randomized trials—again, topics that will be discussed elsewhere in this text—despite their controversies, have demonstrated a clinical benefit of ECMO in the setting of ARDS. These well-conducted randomized trials, in addition to the extensive body of literature (case series, single center reports, and Extracorporeal Life Support Organization (ELSO) registry reviews—far too numerous to reference) combined with growing society guidelines and position papers, serve as a solid foundation of medical science to support the development of ECMO programs worldwide [13].

#### **3. Implementation process**

The clinicians and administrators first determine the need and support for an ECMO program. This multidisciplinary group then operationalizes the care team that needs to be assembled and trained. The team includes clinical, administrative, ancillary, and other stakeholders, which are required to care for the patient and support the infrastructure, while moving the program to implementation.

**29**

*Clinical and Administrative Steps to the ECMO Program Development*

veno-arterial ECMO patient identification, insertion, and management. In addition to the core physician team, there is a need to engage neurologists and infectious disease specialists to understand the therapy and the unique patient care challenges and complications associated with ECMO support. Vascular surgeons often will get involved with cannulation if others are not available or comfortable with placing large bore cannulas—likewise, there is a growing interest by general and trauma

In addition, the Palliative Care team must be involved from the very beginning of program's development and some will advocate, especially in pediatric programs (while the focus of this chapter is on adult program development), Palliative Care providers are automatically involved and consulted on every ECMO case. As such, their understanding of the risks and benefits of ECMO are critical given the marginal outcomes associated with ECMO, even in the best of circumstances [15]. Inclusion of emergency physicians in the team can assist with early identification of patients on presentation to the emergency room, and implementation of protocols in the emergency room for cardiogenic shock and respiratory failure [16].

Administrators from the executive team should be engaged early to help support the creation of structures to accelerate implementation, project management, and assurance of adequate capital and personnel resources for a sustainable program. Financial models, which obviously vary from system (and country) to system, must be considered—and given the amount of resources required to establish and maintain an ECMO program, it is wise to have someone to monitor the financial

Respiratory therapists assist with identifying possible candidates and work closely with the team ensuring the implementation of lung protective strategies. The growth of electronic medical records can allow for daily (if not more frequent) reports of those patients who might be considered for ECMO based upon ventilator

Perfusionists must be engaged to help with setup, oversight of the ongoing treatment and for their skill sets in understanding the complexities of the machines and

Finally, there are implications for laboratory department around testing and blood bank needs; as well as coordinating and consulting with case management, ethics, and chaplains in regard to complex shared decision-making to implement, care for, and remove therapy; and the rehabilitation needs for patients post-ECMO

In addition to leadership described previously, executive nursing leadership, departmental nursing leadership, nursing advanced practice providers (APP), and frontline nursing engagement are fundamental and are essential to assure the success of the program. This includes communication, input and collaboration with policy, procedures and evidence-based protocols, education and competency training of high performing clinical staff, and provision of surveillance and care of patients. Frontline nursing from outside the ICU are often engaged in patient flow and early identification of decompensating acute care patients, who may need to be

*DOI: http://dx.doi.org/10.5772/intechopen.84838*

**3.2 Administrative stakeholders**

surgeons [14].

implications.

testing required.

removal.

**3.4 Nursing**

**3.3 Ancillary services**

settings and arterial blood case results.

#### **3.1 Physician members**

Physicians from Cardiothoracic Surgery, Pulmonary/Critical Care, and Cardiology form the foundation of physician support for veno-veno and

veno-arterial ECMO patient identification, insertion, and management. In addition to the core physician team, there is a need to engage neurologists and infectious disease specialists to understand the therapy and the unique patient care challenges and complications associated with ECMO support. Vascular surgeons often will get involved with cannulation if others are not available or comfortable with placing large bore cannulas—likewise, there is a growing interest by general and trauma surgeons [14].

In addition, the Palliative Care team must be involved from the very beginning of program's development and some will advocate, especially in pediatric programs (while the focus of this chapter is on adult program development), Palliative Care providers are automatically involved and consulted on every ECMO case. As such, their understanding of the risks and benefits of ECMO are critical given the marginal outcomes associated with ECMO, even in the best of circumstances [15].

Inclusion of emergency physicians in the team can assist with early identification of patients on presentation to the emergency room, and implementation of protocols in the emergency room for cardiogenic shock and respiratory failure [16].

### **3.2 Administrative stakeholders**

*Advances in Extracorporeal Membrane Oxygenation - Volume 3*

Acute respiratory failure—regardless of the etiology—remains a complex and difficult problem to treat. Management focuses on treating the primary problem and allowing lung healing via lung protective ventilation strategies, while maintaining adequate oxygenation and ventilation [3]. Unfortunately, morbidity and mortality remain high in patients with severe lung injury, despite implementing standard lung protective strategies. Even for those patients who survive, quality of life can be severely impacted for many years after their initial illness [4]. Acute cardiac failure, or cardiogenic shock, also presents a difficult clinical problem for which even contemporary outcomes are less than ideal. While the most common cause of cardiogenic shock remains pump failure after an acute myocardial infarction, other mechanical problems such as acute papillary rupture (with acute mitral regurgitation), ventricular septal rupture, and myocarditis [5] must be considered [6]. While the use of ECMO for either acute respiratory failure or cardiogenic shock (or often a combination of both) is well-described, in part due to more comprehensive reviews of these topics elsewhere in this text, their incidence and challenges—regardless of the circumstances—serve as a foundation for why there is a substantial interest in developing and growing ECMO programs.

There is growing evidence to support the role of ECMO in the management of these very difficult problems. ECMO has been shown to be an important tool in the armamentarium of any program that serves as a tertiary or referral center for complex cardio-pulmonary pathologies. In fact, excluding the survival benefit that has been demonstrated in patients who are supported with ECMO, there is also growing evidence to suggest that overall outcomes of patients with Adult Respiratory Distress Syndrome (ARDS) or cardiogenic shock treated at "ECMO Program Centers" are better regardless of whether they are treated with ECMO. In other words, the multi-disciplinary and administrative commitment to take care of patients (both adults and children) with complex and difficult cardiac and pulmonary problems can lead to improved outcomes independent of the actual use of

Two randomized clinical trials in patients with severe ARDS support the implementation and increased utilization of ECMO therapy [11, 12]. These randomized trials—again, topics that will be discussed elsewhere in this text—despite their controversies, have demonstrated a clinical benefit of ECMO in the setting of ARDS. These well-conducted randomized trials, in addition to the extensive body of literature (case series, single center reports, and Extracorporeal Life Support Organization (ELSO) registry reviews—far too numerous to reference) combined with growing society guidelines and position papers, serve as a solid foundation of medical science to support the development of ECMO programs worldwide [13].

The clinicians and administrators first determine the need and support for an ECMO program. This multidisciplinary group then operationalizes the care team that needs to be assembled and trained. The team includes clinical, administrative, ancillary, and other stakeholders, which are required to care for the patient and support the infrastructure, while moving the program to implementation.

Physicians from Cardiothoracic Surgery, Pulmonary/Critical Care, and Cardiology form the foundation of physician support for veno-veno and

**2. Background**

ECMO [7–10].

**3. Implementation process**

**3.1 Physician members**

**28**

Administrators from the executive team should be engaged early to help support the creation of structures to accelerate implementation, project management, and assurance of adequate capital and personnel resources for a sustainable program. Financial models, which obviously vary from system (and country) to system, must be considered—and given the amount of resources required to establish and maintain an ECMO program, it is wise to have someone to monitor the financial implications.

#### **3.3 Ancillary services**

Respiratory therapists assist with identifying possible candidates and work closely with the team ensuring the implementation of lung protective strategies. The growth of electronic medical records can allow for daily (if not more frequent) reports of those patients who might be considered for ECMO based upon ventilator settings and arterial blood case results.

Perfusionists must be engaged to help with setup, oversight of the ongoing treatment and for their skill sets in understanding the complexities of the machines and testing required.

Finally, there are implications for laboratory department around testing and blood bank needs; as well as coordinating and consulting with case management, ethics, and chaplains in regard to complex shared decision-making to implement, care for, and remove therapy; and the rehabilitation needs for patients post-ECMO removal.

#### **3.4 Nursing**

In addition to leadership described previously, executive nursing leadership, departmental nursing leadership, nursing advanced practice providers (APP), and frontline nursing engagement are fundamental and are essential to assure the success of the program. This includes communication, input and collaboration with policy, procedures and evidence-based protocols, education and competency training of high performing clinical staff, and provision of surveillance and care of patients. Frontline nursing from outside the ICU are often engaged in patient flow and early identification of decompensating acute care patients, who may need to be considered for ECLS. Since patients might require ECMO at any time, day or night, and given the amount of resources required to initiate and care for such patients, nursing administration must be involved to help develop protocols to organize "phone tree" lines of communication and specialized competent staff schedules to help recruit and arrange appropriate resources on very short notice.

#### **3.5 Critical care transport**

As the program grows beyond supporting the host hospital, it is necessary to engage Critical Care Transport to organize a system to transport patients from outside the facility with appropriate support and skill sets. This engagement is discussed more fully later in the chapter.

#### **3.6 Nonclinical support**

The IT department can help with order set development and the Medical Staff office will need to support the development of privileging requirements to assure consistent skill sets for new team members.

#### **3.7 Establishing relationships with other tertiary centers**

Especially in the situations with VA-ECMO use, long-term myocardial support may be needed. It is essential to build relationships with centers that can provide bridge to long-term LVAD support or transplant.

Additionally, the marketing and public relations departments engage to help in creating materials to help outlying hospitals and physicians have awareness of the program, with knowledge of how to identify patients and when to transport to higher levels of care for consideration of ECMO support.

### **4. Rapid change management**

#### **4.1 Triad leadership structure**

A rapid pace for implementation is best served by a strong triad leadership: experienced physician leaders and champions who are experts in ECMO; nursing leadership; and hospital executives. All need experience in change management and are given support and authority to use project tools and cross-functional influence to fast track project goals across a wide span of departments. These members then must communicate progress within the executive team.

#### **4.2 Change management approach**

Following Kotter's change management theory, a small group of physicians, nursing leadership, and administrators gather to set a vision, determine the feasibility and challenges of the project, then create a shared project plan for the organization, structure, and timeline for implementation of the program [17]. The creation of a Gantt chart with key requirements and milestones is helpful in the early stages of program development—also useful in a sense of accomplishment and motivation of the team. Regular recurrent frequent meetings with agendas driven by a project management tool to assure progress is made on key deadlines, accountability to the individuals and team, and to create a shared message and plan for continued communication. Initial work should focus on best practice, research-based literature review,

**31**

*Clinical and Administrative Steps to the ECMO Program Development*

professional organization review of standards and data, then develop a gap analysis of clinical guidelines, equipment, skill sets, and organizational readiness. This small group should include Cardiothoracic surgeon(s), Pulmonologists, a "C" level executive, the cardiovascular service line, and Intensive Care nursing leadership. A small tactical group allows for more rapid progress through the initial stages and supports creation of a shared vision to accelerate momentum when the inevitable resistance to change surfaces—as well as working through team dynamics, comfort level, and building relationships. This group must strive to produce early wins, however small, to enable the organization to "feel the progress" as more difficult hurdles are faced. These can include shared clinical guidelines, order sets, and eventually patients that

lived thanks to the program—as a true connect to purpose for all involved.

Putting screening guidelines in place and educating the teams on the benefits of ECMO to patients who would otherwise be terminal are very compelling when used

Finally, change in management requires vigilance to newly implemented care processes, or the tendency of the organization will slide back to previous status quo. Tools and strategies that assist in holding on to new skills are most effectively done through audits, constructive timely feedback, continuous process improvement discussions, and accountability to the process. While education can assist in reminding staff of the "why", it is not a sticky tool in terms of cementing new behaviors into a culture.

Once the ECMO program is up and running, collaboration with the quality abstractionist and review of registry data at regular intervals generates quality improvement projects to assure new practice and clinical referral patterns producing the optimal outcomes. It is also a way of preventing politics and rumors from gaining momentum as the facts are reviewed and discussed in larger quality forums. These forums are ideally multi-disciplinary and followed up with tangible action items that have due dates and closed-loop communication back to the CQI team, as the action items are completed.

The obvious hardware required for the program is the ECMO machine. The variables needed to make the correct choice for the program include need for portability of transport between facilities, as well as within the host organization, ease of use, skill sets of those responsible for managing the process, and the capital budget of

In addition to the perfusion/ECMO machine, there is a need for a readily available stock of cannulas in various sizes, as well as for the variety of approaches that may need to be used. In addition, a well-stocked cart that allows the necessary equipment for sterile fields, cut-down, suturing, and possible complications of the cannulation procedures should be available to take to the patient's location, as often the patient is not stable to transport to the OR for the procedure. As these are tools routinely used by perfusionists and cardiothoracic surgeons, they need to be engaged in selecting the appropriate sizes, manufacturers, connectors, introducers, wires and par levels. Many programs, as a function of the need to initiate ECMO therapy on short notice and in many different clinical areas, will create an "ECMO cart" which consist of all the key disposable equipment and tools needed to cannu-

late anywhere at any time (**Table 1** and **Figure 1**).

*DOI: http://dx.doi.org/10.5772/intechopen.84838*

in a story format.

**5. Equipment**

**5.1 Hardware**

the organization.

**5.2 Disposables**

#### *Clinical and Administrative Steps to the ECMO Program Development DOI: http://dx.doi.org/10.5772/intechopen.84838*

professional organization review of standards and data, then develop a gap analysis of clinical guidelines, equipment, skill sets, and organizational readiness. This small group should include Cardiothoracic surgeon(s), Pulmonologists, a "C" level executive, the cardiovascular service line, and Intensive Care nursing leadership. A small tactical group allows for more rapid progress through the initial stages and supports creation of a shared vision to accelerate momentum when the inevitable resistance to change surfaces—as well as working through team dynamics, comfort level, and building relationships. This group must strive to produce early wins, however small, to enable the organization to "feel the progress" as more difficult hurdles are faced. These can include shared clinical guidelines, order sets, and eventually patients that lived thanks to the program—as a true connect to purpose for all involved.

Putting screening guidelines in place and educating the teams on the benefits of ECMO to patients who would otherwise be terminal are very compelling when used in a story format.

Finally, change in management requires vigilance to newly implemented care processes, or the tendency of the organization will slide back to previous status quo. Tools and strategies that assist in holding on to new skills are most effectively done through audits, constructive timely feedback, continuous process improvement discussions, and accountability to the process. While education can assist in reminding staff of the "why", it is not a sticky tool in terms of cementing new behaviors into a culture.

Once the ECMO program is up and running, collaboration with the quality abstractionist and review of registry data at regular intervals generates quality improvement projects to assure new practice and clinical referral patterns producing the optimal outcomes. It is also a way of preventing politics and rumors from gaining momentum as the facts are reviewed and discussed in larger quality forums. These forums are ideally multi-disciplinary and followed up with tangible action items that have due dates and closed-loop communication back to the CQI team, as the action items are completed.
