The administration of surfactant to spontaneously breathing premature infants is not new. The spectrum of methods reported includes aerosol administration over pharyngeal deposition, the use of laryngeal masks, short term intubation, surfactant administration and rapid extubation (INSURE), as well as an approach of keeping premature neonates with spontaneous breathing on continuous positive airway pressure support and administering surfactant by laryngoscopy via a small diameter tube. This way of Less Invasive Surfactant Administration (LISA) or Minimally Invasive Surfactant Therapy (MIST) is increasing in use over the last decade. A first prospective randomized controlled trial demonstrated a significant reduction in the use of mechanical ventilation in LISA patients compared to standard treatment with intratracheal bolus administration of surfactant. Another recent study indicates, that LISA may even be superior to INSURE (Herting, 2013). The search for less invasive methods to deliver surfactant outcomes has developed various new options for the treatment of respiratory distress syndrome in neonates.
Alternative Methods of Surfactant Administration in Preterm Infants
As early as the 1960s lecithin, the main component of natural surfactant, was given as a powder-aerosol to premature infants with respiratory distress syndrome (Herting, 2013). Due to the lack of specific proteins that are essential for the biophysical function of surfactant, these attempts at surfactant administration failed. The first successful trial of surfactant treatment for respiratory distress syndrome was not reported until 1980 (Halliday, 2005). Since then, there have been numerous randomized trials demonstrating the efficacy of surfactant treatment in reducing pulmonary air leaks and increasing survival, as well as assessment of various other aspects of therapy. The studies have revealed that multiple doses may be needed when surfactant is used to treat established respiratory distress syndrome but early or prophylactic treatment is superior for infants with gestational age less than 30 weeks.
Traditionally, surfactant has been given by endotracheal tube (ETT); however, superimposed lung injury from facemask-bag or ETT-bag positive pressure ventilation (PPV) followed by mechanical ventilation may impair surfactant function and trigger an inflammatory response in the lung, leading to bronchopulmonary dysplasia (BPD) (Barbosa, 2017). In recent years, the mounting interest in noninvasive ventilation has led to innovative methods of surfactant administration. Under the common denominator of minimally invasive surfactant therapies (MIST), also term of less invasive surfactant administration (LISA), there are a series of techniques that aim to provide surfactant replacement without intubation and avoid mechanical ventilation. Of the techniques involving brief tracheal catheterization, there are two fundamental methods: the Hobart method and the Cologne method. Other methods of tracheal catheterization are, in general, modifications of one of these techniques. Non-catheterization approaches include the use of laryngeal mask airways and aerosolized surfactant administration.
In premature infants less than 29 weeks, does an evidence-based administration of surfactant protocol, as compared to conventional surfactant administration via endotracheal tube or provider varied practices, decrease the instance of chronic lung disease and mechanical ventilation time?
A research review was conducted using resources found from the UMKC Health Sciences Library, US National Library of Medicine National Institutes of Health, American Academy of Pediatrics, Cochrane Database of Systematic Review, Elsevier’s Science Direct, PubMed, and the National Guideline Clearinghouse. Keywords used for searches included neonatal surfactant, exogenous pulmonary surfactant, methods of surfactant administration, minimally invasive ventilation, and preterm infants. From these inquiries, ten quantitative studies, including randomized control trials, experimental, prospective observational, retrospective analysis, and cohort studies, were reviewed. Three systematic reviews of evidence-based practices with meta-analysis were included, as well as one qualitative study. All studies were ranked based on the level of Melnyk’s Hierarchy of Evidence.
Synthesis of the Evidence
Provide a brief introductory paragraph to introduce the themes and capture that the methods are combined with surfactant administration.
INSURE Method Decreased Mechanical Ventilation Need
The INSURE method, which consists of an INtubation-SURfactant-Extubation sequence, has been reported to reduce the need for mechanical ventilation, the duration of respiratory support, and the need for surfactant replacement in preterm infants with RDS (Chen, 2015). This strategy is widely used throughout the world (Polin, 2014). In randomized clinical trials performed before 2008, the INSURE approach, compared with rescue surfactant administration in infants with RDS, was associated with a significantly reduced need for mechanical ventilation and reduced need for oxygen at 28 days (Stevens, 2007). In an effort to further reduce the risk of injury and chronic lung disease in neonates, less invasive methods of surfactant administration are being developed and tested around the world.
Laryngeal Mask Airway
In a study by Barbosa et al. (2017), patients receiving nasal continuous positive airway pressure (nCPAP) of 5-6 cmH2O, were randomized to the LMA group and ventilated using a size one LMA inserted by the classical technique described by Brain. Lidocaine gel was utilized around the LMA cuff to lubricate and to prevent discomfort during insertion. After insertion, the proximal end of the airway device was connected to a self-inflating bag for PPV. Once a stable heart rate and SpO2 level were achieved, a thin silicone size six French catheter was introduced through the LMA airway tube as a conduit for surfactant administration in two to four aliquots, according to patient tolerance and surfactant reflux, followed by LMA-bag PPV during one or two minutes to obtain SpO2 and heart rate improvement. Once the full dose of surfactant was administered, the LMA was removed and nCPAP restarted.
Minimally Invasive Surfactant Therapy (MIST),
Hobart Method Improves Oxygenation
The Hobart method, first described by Dargaville et al. (2012), uses a semi-rigid vascular catheter to instill surfactant under direct laryngoscopy. This method does not require Magill’s forceps and uses no premedication other than oral sucrose. It does, therefore, largely avoid trauma to the upper airways and vocal cords (Ethawi, 2012). The feasibility trial performed in preterm infants found rapid and sustained improvement in oxygenation, with ultimately a reduction in duration of oxygen supplementation and need for early mechanical ventilation compared to continuation of CPAP (Aguar, 2014). However, no differences were found in respect to overall time of ventilation and incidence of BPD (Dargaville P. A., 2012).
Cologne Method Reduces Mechanical Ventilation Need
Developed in Europe under the leadership of Dr. Angela Kribs, the Cologne method uses a gastric catheter or similar, but requires the aid of the Magill’s forceps to position the tip of the catheter through the vocal cords, and may thus be less widely applicable that the Hobart method. In a controlled multicenter trial in preterm infants of 26-28 weeks gestation mainly managed on nasal CPAP, the Cologne method was compared with continuation of CPAP and intubation for rescue surfactant as necessary. Results favored the MIST approach, with a significant reduction in mechanical ventilation and duration of oxygen therapy (Aguar, 2014). No difference in mortality or severe complications were found (Gopel, 2011).
In another study (SONSURE), the University of Polytechnic Hospital La Fe compared a modification of the Cologne approach with a historical cohort of patients treated with INSURE (Aguar, 2014). Eligible infants were premedicated with atropine prior to a thin catheter being inserted beyond the vocal cords with the aid of Magill’s forceps. Porcine surfactant was instilled over one to three minutes, and the catheter immediately removed. No significant differences were noted regarding need for intubation and mechanical ventilation in the first 72 hours. However, an unexpected trend towards reduction in the incidence of NEC was noted in the SONSURE group (Aguar, 2014).
The Levels of Prevention Model, by Leavell and Clark, is most applicable to this PICOT research question. By suggesting that the natural history of any disease exists on a continuum, with health at one end and advanced disease at the other, the model delineates three levels of the application of preventive measures that can be used to promote health and arrest the disease process at different points along the continuum with the goal of maintaining a healthy state and preventing disease or injury (Currentnursing.com, 2012). Primary prevention, which seeks to prevent a disease or condition at a pre-pathological state, requires action prior to the onset of disease, therefore, removing the possibility the disease will ever occur. Secondary prevention identifies illnesses or conditions at an early stage with prompt intervention to prevent or limit disability. Tertiary prevention occurs after a disease or disability has occurred and the recovery process has begun (Leavell and Clark’s Three Levels of Prevention, 2018). The intent of tertiary prevention is to halt the disease process and prevent further complications. The secondary prevention stage is most relevant to the administration of surfactant to premature infants via minimally invasive techniques with a goal of preventing injury and chronic lung complications. Utilization of this model to determine the effectiveness of less invasive administration of surfactant will determine a need for policy and process change in the NICU setting.
Approval for this project will be requested from the Internal Review Board at the University of Missouri Kansas City. Contact with the physicians and advanced practice nurses associated with Sunflower Neonatology in Overland Park, Kansas will occur to discuss projected change of practice and implementation in the clinical setting at Overland Park Regional Medical Center. Funding for this research project will be obtained through grants from the medical offices at the aforementioned care setting. Projected costs include salary for data collection personnel as well as additional training and in-service requirements for clinicians, and information packets and materials required for process change.
This project will be a single center, quasi-experimental quantitative study that will determine the effectiveness of minimally invasive surfactant therapy (MIST) at decreasing the occurrence of bronchopulmonary dysplasia (BPD) in preterm infants. BPD, formerly know as chronic lung disease, is diagnosed by an infant’s need for supplemental oxygen at a gestational age of 36 weeks or greater. Data collected will include method of administration and ventilation, need for mechanical ventilation, adverse reactions, and prevalence of required supplemental oxygen at greater than 36 weeks gestation.
Participants and Setting
Infants from a Level III Neonatal Intensive Care Unit in the greater Kansas City metro will be focus of this study. As the region’s highest level NICU, with an average daily census of 43 patients, the facility should provide adequate sample size to conduct the study. Beginning January 1, 2019 until December 31, 2020, or until the project is otherwise deemed unsafe, infants with a gestational age of less than 29 weeks and a diagnosis of RDS, free of major congenital anomalies, will receive treatment using MIST, more specifically the Hobart method with continuous positive airway pressure, for the administration of surfactant. The control for this study will utilize retrospective data collection of infants, who meet the same criteria as those in the intervention group, who received the current standard of practice involving intubation and positive pressure ventilation during administration.
EBP Intervention and Implementation
Lewin’s Change Management Model will be used to incorporate the new method into practice. Designed by Kurt Lewin in the 1950s (Anastasia, 2015), this model consists of three key stages; unfreeze, change, and refreeze. The first stage, unfreeze, involves preparing the organization for change. Because many people are naturally resistant to change, this phase is crucial because it addresses the need to change existing practice and prepares individuals for the process alteration. The middle stage, change, is where the actual transition occurs in this model. Important factors during this stage include strong leadership and supportive reassurance to guide the practice in the right direction and ensure a smooth transition (Anastasia, 2015). Time and effective communication are key to the success of this stage. The third and final stage of the model, refreeze, involves the time when the change has finally been recognized and incorporated throughout the organization. This stage requires the help of the clinicians utilizing the new method to ensure that all colleagues are following the new practice and ensure the new practice remains the standard of care. The renewed sense of stability found during this stage restores individuals’ confidence in the acquired change (Anastasia, 2015).
Facilitators and Barriers
Facilitators of this process change include the neonatologists, neonatal nurse practitioners, nurses, and respiratory therapists directly involved in the care and management of NICU patients. Ongoing practice changes in the organization revolve around minimizing the use of mechanical ventilation to minimize lung injury, this practice change would simply expand on the already strong push to lower the incidence of BPD among the unit’s most vulnerable population. The less invasive practices would allow the nursing and respiratory staff to have increased involvement in the administration of surfactant; current practice (INSURE method) requires the practitioner to intubate prior to administration and thus can delay treatment when other responsibilities take precedence.
Barriers to the project include resistance to change and lack of knowledge around evolving practice. Although care providers undoubtedly have the infants’ best interest at heart, the dreaded that’s how we’ve always done it mentality can be challenging to overcome when implementing practice change. It would be vital to educate staff on the benefits associated with the new techniques to ensure the acceptance and utilization of the new protocol.
Evidence Based Practice Model
The Iowa Model focuses on the importance of the healthcare system as a whole and using research to guide decisions in practice (Dontje, 2007). The first step identified in this model is to identify a trigger, either problem-focused or knowledge-focused, that will initiate the need for change. In this case the problem-focused trigger of increased rates of BPD among premature neonates, has initiated a need for change to produce a less invasive method of surfactant administration to decrease the incidence. The second and third steps of the Iowa model include reviewing and critiquing relevant literature, and identifying research evidence that supports the change in clinical practice (Dontje, 2007). As evidenced by the attached evidence table (Appendix A), this level has been achieved. The final step encompasses implementing the change and monitoring the outcomes (Dontje, 2007).
Internal and External Validity
Information on alternative methods of surfactant administration as well as the latest research will be presented and readily available for clinician, nursing, and respiratory staff. Because this is a multidisciplinary process change, it will be strongly encouraged for all staff to discuss and educate themselves and colleagues on the benefits of the proposed practice change. The ability to replicate this process change would be easily achieved in units with similar patient populations. The less invasive method of administration would be applicable to older infants with other pulmonary complications as well, not just those less than 29 weeks gestation with RDS.
The primary outcome of this study will calculate the incidence of required supplemental oxygen at greater than 36 weeks gestation, thus diagnosing the infant with BPD. Secondary outcomes being measured will include length of time requiring mechanical ventilation, doses of surfactant required, hours of life at administration, and adverse events during administration. Following completion of the study, findings will be made available to all care providers showing either support or denial of proposed change.
Data will be collected from the bedside flowsheet as well as the electronic medical record. Limitations to this include variations in documentation by individual providers. The primary outcome will be easily documented; however, secondary outcomes will be more difficult to accurately account for. Education regarding importance of accurate and thorough documentation would be essential.
Quality of Data
Data will be collected weekly by the author and statistics organized in spreadsheets on secured drives to maintain patient confidentiality. All data will be obtained from information documented by the care team on the patients’ medical records. Inaccuracies in documentation pose a significant threat to the validity of the data, it will be imperative that clinical staff maintain thorough and accurate records.
By utilizing the Mann-Whitney U test, Fischer’s Exact test, and paired t-tests the author will be able to demonstrate the likeness or differences among the two variables (Dargaville P. A., 2012); INSURE and MIST administration. It is suspected that the minimally invasive method of surfactant administration will yield less incidence of BPD in preterm infants thus leading to the acceptance and continued utilization of the new practice.
The prevalence of BPD is one of the major challenges of caring for preterm infants. Through research and this evidence-based practice study, it is proposed that the use of the Hobart method to administer surfactant to neonates of less than 29 weeks gestation will result in a lower incidence of BPD. The proposed practice change utilizes a minimally invasive technique which has been show to induce less trauma than the current standard of practice.