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Innovations in technology--Novalung[R] iLA: challenges for the field of critical care nursing.

The introduction of a new interventional technology requires careful consideration of policy, safety, and staff education. There is limited literature on patient care in Novalung[R] interventional lung assist (iLA) therapy. This is particularly true of nursing care. As a result, it was necessary to formulate a plan to prepare for patients requiring a bridge to lung transplantation with this device within the medical surgical intensive care unit (MSICU) in our hospital, the Toronto General Hospital. Central to this plan was the ability to deliver education and training guidelines that would allow for initial care without undue confusion or anxiety on the part of staff. We appreciated that these initial nursing guidelines would change and evolve during implementation, but we needed a starting point. Information relayed to staff included an introduction to the technology coupled with the anticipated responsibilities of the critical care nurse. An educational plan was devised that would assist in the nursing management of patients requiring this device. The formulation of this plan of care included strategies to deliver the information, as well as to overcome the inability of some staff to attend the information sessions. This plan provided a base on which to build, as experience was gained once patients requiring the Novalung[R] were admitted to the MSICU. In this article, the author discusses the introduction of this new advancement in extracorporeal gas exchange into an adult critical care setting.

Novalung[R] technology

In 2002, Novalung[R] GmbH started operating in Hechingen, Germany, with the introduction of new devices for advanced protective ventilation that provided CO2 removal and O2 delivery for patients with respiratory or ventilatory failure (Carl, 2002). The Novalung[R] iLA device is an extracorporeal membrane ventilator that allows for oxygen and carbon dioxide gas exchange to occur by simple diffusion (Carl, 2002). Within our MSICU, the Novalung[R] iLA is used exclusively for bridging patients with end stage lung failure to transplantation. It has also been used in Europe for patients with severe acute lung failure due to acute respiratory distress syndrome, inhalation injury, severe pneumonia, chest injury, foreign body aspiration, and after thoracic surgical interventions (Carl, 2002).

The Novalung[R] iLA is a low-gradient device designed to operate without the help of a mechanical pump. This necessitates an adequate mean arterial blood pressure. The Novalung[R] iLA is attached to the systemic circulation by percutaneous cannulation (a preferred method) to the femoral artery and vein receiving only part of the cardiac output (1 L/min to 2 L/min) for extracorporeal gas exchange (Fischer & Strueber, 2006).

The Novalung[R] iLA maximizes blood and gas mixing through a low-resistance polymethylpentene (PMP) plastic gas exchange module with diffusion membranes woven into a complex configuration of hollow fibres and bundles (Carl, 2002). As blood enters the device through an inlet connector, it flows into the pre-chamber, and micro air bubbles that may have entered the device are removed through the de-airing ports. These two de-airing ports are situated at the top on both sides of the iLA. This membrane also facilitates priming of the device. An oxygen supply is connected to the upper gas connector with a lower gas connector open to the atmosphere at all times for gas exhaustion (Fischer et al., 2006). The blood then flows into the main chamber where the gas exchange occurs. The oxygenated and decarboxylated blood is returned to the patient's systemic arterial circulation. The device allows the patient's carbon dioxide levels and pH to be adjusted to normal levels by regulating the rate of gas flow (Fischer et al., 2006). While the driving power for this mode is left ventricular output, other situations such as a low cardiac output or hypoxic lung failure may require a blood pump to divert a larger amount of blood from the venous system through the iLA (Fischer & Strueber, 2006) (See Figures One and Two).

Extracorporeal membrane oxygenation (ECMO)

Previously, ECMO had been the only option used in our MSICU for patients with acute reversible cardiac or respiratory failure who did not respond to conventional medical treatment. ECMO is similar to the heart-lung bypass used during coronary artery bypass surgery. Table One includes a summary of the similarities and differences between ECMO and Novalung[R] iLA.

[FIGURE 1 OMITTED]

[FIGURE 2 OMITTED]

Contraindications to the use of the Novalung[R] iLA

Heparin-induced thrombocytopenia is a contraindication for the use of Novalung[R] iLA because the PMP membrane surface is treated with a heparin coating, which provides a biocompatible and non-thrombogenic surface (Fischer & Strueber, 2006). Other contraindications include unstable hemodynamics where a sufficient perfusion pressure of 60 mmHg cannot be established such as in cardiogenic or septic shock, or peripheral arterial occlusive vascular disease that would impair perfusion of the lower limbs after cannulation. These conditions would interfere with adequate blood flow through the device and back to the patient (Carl, 2002).

Clinical requirements

The clinical requirements for initiation of this therapy include a critical care setting with an experienced team of physicians and perfusionists to operate the Novalung[R] iLA, as well as an experienced team of critical care nurses and respiratory therapists to monitor the Novalung[R] iLA (Carl, 2002).

Education

In order to provide initial information about the Novalung[R] iLA to all staff who would be caring for patients with this new technology, we coordinated lead personnel including the nurse manager, critical care and lung transplant physicians, and the MSICU clinical educator with a mandate to plan the project. Multiple meetings were held within the MSICU to determine the communication means and content of initial information, the participants delivering that information and the identification of all staff who would require the information. Our lung transplant surgeons and an MSICU physician were selected to present the initial information. Core material focused on the concept of the Novalung[R] iLA device, anticipated patient cases, responsibilities of the team members involved with this project and the potential impact on the workload and routine of the MSICU. The staff targeted for this information included critical care, thoracic and lung transplant physicians, perfusionists, MSICU nurses, and respiratory therapists.

Nursing sponsored weekly "Lunch and Learn" sessions and included the transplant and MSICU physicians. One challenge to these information sessions sometimes included an extremely busy environment in the MSICU and the uncertain availability of physicians. A visiting physician from Germany with Novalung[R] iLA experience and the author of published papers on the Novalung was also available to present information on the device. The Novalung[R] iLA was presented primarily to the nurses because nurses would spend the greatest amount of time caring for and monitoring these patients. While the physicians in the MSICU were also included, their involvement was anticipated to be minimal, as the transplant team and the assigned lead MSICU physician for the Novalung[R] iLA would be the primary care physicians. All educational sessions were well attended by everyone, subject only to workload constraints.

The information the physicians presented included a detailed review of the Toronto lung transplant program, the history of the Novalung[R] iLA and its use in lung transplantation in Europe, technical information on the Novalung[R] iLA, objectives of the iLA therapy, and inclusion and exclusion patient criteria for the use of this device. A coordinator was introduced and would act as an additional resource for the management of the Novalung[R] iLA.

Arrangements were made for the Novalung[R] iLA company consultant in North America to visit our institution to provide the nursing staff with additional technical information. The information sessions by the company consultant were presented in the afternoons and evenings over a three-day period and included a product demonstration. This allowed the nurses to actually view and handle the equipment.

Due to limited literature on the Novalung[R] iLA, our primary sources for information were the visiting physician from Germany, the lung transplant physicians, and the perfusionists. Internet information was also helpful, as several articles were found on technical data and use that aided in understanding the device. While attendance at the information sessions was open to all nurses in the MSICU, a decision was made by the team members involved in the project to initially select experienced nursing staff to care for patients on the Novalung[R] iLA. This decision was made because greater experience in caring for complex patients, more advanced critical thinking skills, and the higher likelihood of having cared for a patient on ECMO would all contribute to an increased nursing comfort level.

To further enhance nursing education for staff, 10 nurses attended an ECMO course at the Hospital for Sick Children (HSC) in Toronto, Ontario. This three-day workshop consisted of two days of lectures on theory and application of this mode of treatment and a half-day of viewing and working with the actual ECMO equipment. While our needs were different than HSC's, the workshop provided information to the staff that was relevant to the overall understanding of Novalung[R] iLA and ECMO patients. The nurses in the MSICU were very proactive in sharing information on the ECMO workshop. Nurses not directly involved in the initial Novalung[R] iLAcases sought information about the care and management of these cases in the MSICU.

Preparing nursing guidelines

As a baseline, we relied on previous ECMO guidelines (Morris, Damilatis, & Twa, 2004) and the experience of nurses who had the opportunity to nurse patients on ECMO. Nurses thought that the ECMO guidelines could act as a framework for patients on the Novalung[R] iLAuntil we actually experienced a case and had first-hand experience as to the similarities and differences between ECMO and Novalung[R] iLA patients. Additionally, we incorporated the product information, the experience of the physicians and perfusionists who had worked with ECMO and the Novalung[R] iLA, and the specific management orders into the care guidelines of these patients.

The care and management of patients with the Novalung[R] device were carefully monitored by the nurses to ensure compliance, as well as adherence to existing critical care standards. The College of Nurses of Ontario and the Registered Nurses Association of Ontario best practice guidelines regarding the care of patients were maintained at all times. Adherence to the management orders of Novalung[R] iLA patients was also incorporated into the nursing guidelines, which included specific laboratory and diagnostic tests.

Activated clotting time (ACT). During an information session with the physicians, it was decided, in concert with the perfusion department, that the laboratory test that would determine the levels of anticoagulation used with the Novalung[R] iLA would be an ACT. This test is used for bypass in our operating rooms and was viewed to be appropriate for these cases. A representative from the company supplying ACT diagnostic equipment was contacted and arrangements were made to provide education for the nurses on the procedure for ACT testing. The Novalung[R] iLA coordinator was responsible for obtaining the vials for the ACT test and ensuring adequacy of supply when Novalung[R] iLA cases were in the MSICU.

Safety. Due to the anticipated increased workload in caring for Novalung[R] iLA patients, two experienced critical care nurses with previous practical knowledge and skill nursing ECMO patients were assigned to patients on the Novalung[R] iLA. This allowed for continuity of care during break coverage and as a resource in decision-making while caring for these patients. The physicians in the MSICU, lung transplant, perfusion staff and a Canadian Novalung[R] iLA company representative were available at all times to assist in identifying problem situations with the device and to provide advice for an appropriate resolution to these situations. Emergency call numbers for product support and for deviation in patient status were also available from the Novalung[R] iLA company.

Useful tools

A complete resource manual for the Novalung[R] iLA was developed to further assist in the care of these patients. This included the Novalung[R] iLA company literature with detailed background on the device, articles on the Novalung[R] iLA and the nursing guidelines. The Novalung[R] iLA nursing guidelines (Gordon, Barrans, McCaughey, & Romano, 2007) included the ECMO guidelines with adaptations to the specific nursing considerations and monitoring of the device. A Novalung checklist to monitor tasks such as hourly checks on ACT, observing the device for blood clots, de-airing the device (burping) and blood work was also devised to further assist the nurses looking after Novalung[R] iLA patients. In addition, a Novalung[R] iLA cart was assembled and arranged with the supplies required for the preparation and ongoing care of Novalung[R] iLA patients. The cart could be moved into the patient's room for easy access for the nurses.

Lessons learned

The lessons we learned during our implementation process have potential implications for the integration of any new therapy into practice. The introduction of this leading-edge technology into the MSICU required teamwork for advance planning and for the ultimate care for these patients. It was essential that communication be frequent and thorough among all of the MSICU physicians, lung transplant physicians, MSICU nursing staff, and the perfusion department. A consistent plan of care and the effective implementation of that plan were essential to the success of the patients relying on this new technology. The initial selection of experienced critical care nurses to care for these patients proved to work well, as this technology was introduced in our MSICU. Less experienced critical care nurses were encouraged to participate and to observe the patient and the required nursing care. When needed, they would assist the nurses caring for these patients.

Going forward

The first North American implantation of the Novalung[R] iLA was in February 2007 at the Toronto General Hospital. Since the initial patient, we have cared for 13 patients on Novalung[R] iLA therapy. The nursing guidelines continue to evolve, as we gain more experience and familiarity with this device. The nursing staff involved with the care of these particular patients continues to grow through interest and the assignment of nurses has been altered to allow a nurse who has cared for these patients to be partnered with a nurse who has had minimal experience with extracorporeal devices.

A two-day Novalung[R] iLA education workshop has been prepared by perfusion, nursing and medical staff for the nurses and respiratory therapists to further enhance our unit's ability to provide the best possible care to these patients. A series of lectures is provided by the perfusion staff covering extracorporeal devices with the primary focus on the Novalung[R] iLA. The lectures consist of a history of extracorporeal devices, equipment and function, indications for this therapy, management and troubleshooting. Nursing guidelines are also discussed addressing patient care, monitoring the Novalung[R] iLA device and safety. A half-day simulation experience with a critical care physician and perfusion staff allows a hands-on experience with troubleshooting problems that may arise with a change in the patient's condition and/or equipment while they are on this device. As well, several hours are spent in the operating room with the perfusion staff to allow the participants to view cardiopulmonary bypass and its associated care and maintenance. The workshop has added additional information and expertise to the staff who will be caring for patients requiring Novalung[R] iLA therapy in our MSICU. These types of approaches and initiatives since project inception have served to minimize confusion and anxiety among our MSICU nursing staff as they incorporate use of this new therapy into their critical care practice. They are the first North American nurses to do so.

Acknowledgement

The author acknowledges the contributions of the development of the Nursing Care Guidelines and Tools from: Lesley Barrans, RN, BScN, CCRN, Linda McCaughey, RN, BScN, CCRN, Elizabeth Romano, RN.

References

Bein, T., Weber, F., Phillip, A., Prasser, C., Pfeifer, M., Schmidt, F.X., et al. (2006). A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnea. Critical Care Medicine, 34, 1372-1377.

Carl, M.D. (2002). Novalung[R] iLA membrane ventilator indications and practical applications. Talheim, Germany: Novalung GmgH Egerten 3D-74388.

Fischer, S., Simon, A.R., Welte, T., Marius, M., Gohrbandt, B., Gottlie, J., et al. (2006). Bridge to lung transplantation with the novel pumpless interventional lung assist device Novalung[R]. Thoracic Cardiovascular Surgery, 131, 719-723.

Fischer, S., & Strueber, M. (2006). The Novalung[R] iLA membrane ventilator: Technical aspects. Retrieved September 10, 2008, from http://www.ctsnet.org/

Gordon, E., Barrans, L., McCaughey, L., & Romano, E. (2007). Novalung nursing management guidelines. Toronto, ON: Toronto General Hospital, University Health Network.

Morris, D., Damilatis, P., & Twa, B. (2004). ECMO nursing management guidelines. Toronto, ON: Toronto General Hospital, University Health Network.

University of Michigan Health System. (2008). Extracorporeal membrane oxygenation (ECMO). Retrieved September 10, 2008, from http://www.med.umich.edu/ecmo/

von Mach, M.A., Kaes, J., Omogbehin, B., Sagoshen, I., Wiechelt, J., Kaiser, K., et al. (2006). An update on interventional assist devices and their role in acute respiratory distress syndrome. Lung, 184, 169-175.

By Elizabeth Gordon, RN, BEd, BN

Elizabeth Gordon, RN, BEd, BN, Clinical Educator MSICU, University Health Network, Toronto General Hospital Division, Toronto, ON. E-mail elizabeth.gordon@uhn.on.ca
Table One: Comparison of ECMO and Novalung[R] iLA

ECMO                          Novalung[R] iLA

* Works in two ways:          * Arterio-venous percutaneous
veno-arterial supporting      attachment of the pumpless
both the heart and lungs      shunt provides a primary
and veno-venous bypass        function of carbon dioxide
supporting only the lungs.    exchange due to the inflow of
Both methods require a        arterial blood (Fischer &
blood pump.                   Strueber, 2006).

* Functions to provide        * Allows for oxygen and carbon
oxygenation, cardiac and      dioxide gas exchange to occur
hemodynamic support, as       by simple diffusion, prevents
well as carbon dioxide        and rapidly reverses
elimination (University       hypercapnia and normalizes pH.
of Michigan Health            * Prevents ventilator-associated
System, 2008).                lung injury.

* Potential significant       * Potential side effects such as
side effects such as          bleeding complications and
hemolysis, infection,         ischemia of the lower limb can
renal insufficiency, and      occur as a consequence of wide
bleeding complications        bore cannulation of the femoral
(Fischer et al., 2006).       artery (Bein et al., 2006).

* Expensive treatment         * Pumpless Novalung[R] iLA can
requiring specialized         be used in centres where ECMO
equipment and centres         is not available and used for
with trained and              extended periods of time with
experienced support           the longest recorded time of 100
staff (Bein et al., 2006).    days (von Mach et al., 2006).
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