Scholarly Journals--Accepted

  • A standardized respiratory care driven guideline and care pathway in the electronic medical record for status asthmaticus leads to decreased length of stay. Merrick Lopez, MD, Michele Wilson, MS, RN, CNS, Ekua Cobbina,MD,  Danny Kaufman, RCP, Julie Fluitt, RN, Michele Grainger, RCP, Robert Ruiz, RN, Gulixian Abudukadier , RN, Michael Tiras, RCP, Bronwyn Carlson, MD, Jeane Spaid, RN, Kim Falsone , RN, Invest Cocjin, RN,  Anthony Moretti, MD, MBA, Chad Vercio, MD,  Cynthia Tinsley, MD, Harsha Chandnani, MD, Carlos Samayoa, MPH, Carissa Cianci, RN, James Pappas, MD, MBA. Submitted to Pediatric Quality and Safety, December 2022.  (03/2023)

Scholarly Journals--Published

  • Szaflarski JP, Devinsky O, Lopez M, Park YD, Zentil PP, Patel AD, Thiele EA, Wechsler RT, Checketts D, Sahebkar F. Long-term efficacy and safety of cannabidiol in patients with treatment-resistant epilepsies: 4-year results from the expanded access program. Epilepsia. 2022 Dec 20. doi: 10.1111/epi.17496. Epub ahead of print. PMID: 36537757. Objective: Cannabidiol (CBD) expanded access program (EAP), initiated in 2014, provided add-on CBD to patients with treatment-resistant epilepsy (TRE) at 35 US epilepsy centers. Prior publications reported results through December 2016; herein, we present efficacy and safety results through January 2019. Methods: Patients received plant-derived highly purified CBD (Epidiolex®; 100 mg/mL oral solution), increasing from 2-10 mg/kg/d to tolerance or maximum 25-50 mg/kg/d dose, depending on the study site. Efficacy endpoints included percentage change from baseline in median monthly convulsive and total seizure frequency and ≥50%, ≥75%, and 100% responder rates across 12-week visit windows for up to 192 weeks. Adverse events (AEs) were documented at each visit. Results: Of 892 patients in the safety analysis set, 322 (36%) withdrew; lack of efficacy (19%) and AEs (7%) were the most commonly reported primary reasons for withdrawal. Median (range) age was 11.8 years (0-74.5), and patients were taking a median (range) 3 (0-10) antiseizure medications (ASMs) at baseline; most common ASMs were clobazam (47%), levetiracetam (34%), and valproate (28%). Median top CBD dose was 25 mg/kg/d; median exposure duration was 694 days. Median percentage reduction from baseline ranged from 50%-67% for convulsive seizures and 46%-66% for total seizures. Convulsive seizure responder rates (≥50%, ≥75%, and 100% reduction) ranged from 51%-59%, 33%-42%, and 11%-17% of patients across visit windows, respectively. AEs were reported in 88% of patients and serious AEs in 41%; 8% withdrew because of an AE. There were 20 deaths during the study deemed unrelated to treatment by the investigator. Most common AEs (≥20% of patients) were diarrhea (33%), seizure (24%), and somnolence (23%). Significance: Add-on CBD was associated with sustained seizure reduction up to 192 weeks with an acceptable safety profile and can be used for long-term treatment of TREs. Keywords: antiseizure medications; convulsive seizures; treatment-resistant seizures. (12/2022)
  • Porritt RA, Binek A, Paschold L, Rivas MN, McArdle A, Yonker LM, Alter G, Chandnani HK, Lopez M, Fasano A, Van Eyk JE, Binder M, Arditi M. The autoimmune signature of hyperinflammatory multisystem inflammatory syndrome in children. J Clin Invest. 2021 Oct 15;131(20):e151520. doi: 10.1172/JCI151520. PMID: 34437303; PMCID: PMC8516454. (10/2021)
  • Porritt RA, Paschold L, Rivas MN, Cheng MH, Yonker LM, Chandnani H, Lopez M, Simnica D, Schultheiß C, Santiskulvong C, Van Eyk J, McCormick JK, Fasano A, Bahar I, Binder M, Arditi M. HLA class I-associated expansion of TRBV11-2 T cells in multisystem inflammatory syndrome in children. J Clin Invest. 2021 May 17;131(10):e146614. doi: 10.1172/JCI146614. PMID: 33705359; PMCID: PMC8121516. (05/2021)
  • Lopez Merrick R, Abd-Allah Shamel, Deming Douglas D, Piantini Rebeca, Young-Snodgrass Amy, . . . Sheridan-Matney Clare. (2014). Oral, Jaw, and Neck Injury in Infants and Children From Abusive Trauma or Intubation?. Pediatr Emerg Care, 30(5), 305-310. PMID: 24759489 Objectives The objective of this study was to identify the incidence of oral, jaw, and neck injury secondary to endotracheal intubation in young children. Methods This prospective observational study was conducted in the pediatric intensive care unit at a level 1 trauma center. From October 1998 to January 1999 and November 2007 to April 2008, all intubated patients younger than 3 years with no prior oral procedures were examined within 24 hours of intubation. A standardized form was used to record injuries. Separately, medical records were reviewed for prior injuries. Chi-square/Fisher exact test was used for statistical analysis. Results Of 105 patients included in the study, 12 had oral, jaw, or neck injury. One patient had a hard palate injury from a pen cap in his mouth during a seizure. Another broke a tooth biting the laryngoscope blade (the only injury directly attributable to intubation). The remaining 10 patients were determined to be those who experienced abusive trauma. The overall incidence of injury directly from intubation was 0.9%. Oral, jaw, and neck injuries were all significantly associated with abusive trauma (P < 0.001). Eleven patients had difficult intubations: 9 had no injuries, 1 experienced abusive trauma and the second was the patient who broke his tooth during intubation. Conclusions Oral, jaw, or neck injury in young children is rarely caused by endotracheal intubation, regardless of difficulty during the procedure. (05/2014) (link)


  • Abraham, A., Tan, J., Cana, J., Soeharsono, C., Fenison, A., Kim, V., Sung, H., Avesar, M., Lopez, M., Soneji, M., Chandnani, H. Predictive Factors for ICU Admission in Patients with MIS-C. Abstract presented as an oral presentation at the World Federation of Pediatric Intensive and Critical Care Societies, Cape Town, SA., 2022.  (04/2022)
  • Cana, J., Abraham, A.,  Lopez, M., Guglielmo, M., Chandnani, H. Case Series of Air Leak Syndrome and Bacterial Superinfection in Pediatric SARS-CoV2 Infection. Abstract presented at poster presentation at the World Federation of Pediatric Intensive and Critical Care Societies, Cape Town, SA., 2022.  (04/2022)
  • Introducing an Early Mobilization Protocol of Ventilated Infants in a Pediatric ICU Gamboa, B., Wilson, M., Chandnani, H., Diaz, K., Bennett, A., & Lopez, M. (2022). 1290: INTRODUCING AN EARLY MOBILIZATION PROTOCOL OF VENTILATED INFANTS IN A PEDIATRIC ICU. Critical Care Medicine50(1), 646. Presented Virtually at SCCM April 2022 Introduction: Progressive mobility has been shown to prevent neuromuscular degeneration and improve patient outcomes by decreasing ventilator days, hospital lengths of stay, and costs. Our Pediatric Intensive Care Unit (PICU) did not have a standardized practice of mobilizing ventilated patients. Implementing holding practices may be a form of progressive mobilization for infants and young children. The goal of this study is to implement an early mobilization (EM) protocol for intubated infants and describe observed physiologic effects. Methods: This pilot study was implemented in a 25-bed PICU at a tertiary care hospital. Staff (nurses, physicians, respiratory therapists, and pharmacists) were given pre- and post-implementation surveys to assess their perceived beliefs, barriers, and attitudes towards EM of intubated patients. Education on the protocol methods, and EM benefits and safety was shared. The protocol was implemented over 45 days in March 2021. Data collection included vital signs prior to mobilization events and prior to transferring back to cribs. Parental surveys were collected after the initial mobilization event. Results: A total of 26 mobilization events were observed among 8 mechanically-ventilated infants. Pre- and post-implementation surveys demonstrated that concern for patient safety was the highest perceived barrier among staff. This concern decreased by 24% post-implementation. Concerns for insufficient staff and time increased after implementation. Additionally, statistically significant decreases in heart rate and respiratory rate were noted during EM and holding. Noadverse events (i.e., unplanned extubations, catheter dislodgments) were reported. All parents (n=8) believed they were a valuable part of the healthcare team and perceived that EM positively impacted their infant, was done in a safe manner, and helped their infant relax. Conclusions: Implementation of a protocol that standardized EM of ventilated infants demonstrated statistically significant decreases in physiologic parameters with mobilization events without adverse events. This project demonstrated that EM of ventilated infants can be done in a safe manner with benefits for both the patient and family. (04/2022)
  • The Use of Vitamin K for Coagulopathy in Critically Ill Children Smith, C., Sierra, C., Valencia, R., & Lopez, M. (2022). 1008: THE USE OF VITAMIN K FOR COAGULOPATHY IN CRITICALLY ILL CHILDREN. Critical Care Medicine50(1), 501. SCCM Virtually 2022. Presented virtually at SCCM April 2022.  Introduction: Coagulopathy is associated with increased mortality in children treated in the intensive care setting. Recommended management of vitamin K-deficient coagulopathy is vitamin K (VK) administration. However, limited data support this practice outside reversal of VK antagonists. The goal of this study was to evaluate the effectiveness and safety of VK administration for coagulopathy in critically ill children and determine a relationship between VK dose and change in prothrombin time (PT) and international normalized ratio (INR).Methods: This retrospective cohort study reviewed electronic medical records of patients ≤17 years who received VK for acute coagulopathy in the pediatric intensive care unit between January 2013 and January 2021. Patients who receiving VK antagonists were excluded. Effectiveness data included change in PT/INR after VK administration. Safety data included incidence of hypersensitivity reaction or anaphylaxis. Change in PT/INR was analyzed using Student’s t-test (α=0.05). Regression analysis was used to examine the relationship between VK dose and INR change accounting for receipt of fresh frozen plasma (FFP). Results: A total of 223 patients (median age 3.9 years, range 22 days-17.8 years) received VK. A median of 3 doses (range 1-14) and 0.14 mg/kg (range 0.02-1.24 mg/kg) were given, most frequently intravenously (94%). The most common admitting diagnoses were infection/sepsis (28%) and trauma (15%). Neurologic conditions were the most common comorbidity (41%). Most patients (98%) had at least one risk factor for VK deficiency, the most common being nothing by mouth status (80%) followed by receipt of antimicrobials (77%). Less than half (40%) of patients received FFP within 12 hours of VK. Mean PT/INR was 21.1/2.0 prior to VK administration. After the first dose of VK, the PT and INR decreased by 4.2 (SD=8.33, p< 0.001) and 0.5 points (SD=0.98, p< 0.001) to a mean of 16.9 and 1.6, respectively. No hypersensitivity/anaphylaxis occurred following VK administration. No linear relationship was found between VK dose administered and change in PT/INR. Conclusions: Administration of VK is an effective and safe treatment for VK deficient coagulopathy in critically ill pediatric patients. Further study is needed to determine if a relationship between VK dose and PT/INR change exists. (04/2022)
  • Implementing a Standardized Respiratory Care Driven Electronic Pathway for Status Asthmaticus Lopez, M., Abudukadier, G., Chandnani, H., Cianci, C., Cobbina, E., Fluitt, J., ... & Wilson, M. (2022). 1287: IMPLEMENTING A STANDARDIZED RESPIRATORY CARE-DRIVEN ELECTRONIC PATHWAY FOR STATUS ASTHMATICUS. Critical Care Medicine50(1), 644. Presented at SCCM, Virtual. April 2022. Winner of Goldstar Award for Excellence.  INTRODUCTION:   Status asthmaticus (SA) is a common reason for pediatric hospitalization. The goal of this study is to describe the impact of a standardized pathway for SA in the electronic medical record(EMR) of a pediatric intensive care unit (PICU).    METHODS:   This quality improvement initiative was implemented in a 25-bed multidisciplinary PICU in a tertiary children’s hospital. A standardized respiratory score (RS) was adopted and internally validated by staff – physicians, nurses, and respiratory care practitioners (RCPs) in February 2017 to use for patients admitted with SA. The RS was then used to determine weaning schedules for Albuterol and steroid therapies. Pharmacy and information technology(IT) staff developed an electronic SA pathway within our EMR system, using best practice alerts (BPAs). These BPAs informed staff to initiate the pathway, wean/escalate treatment, transition to oral steroids, transfer level of care, and complete discharge education. In October 2018, the clinical pathway was implemented in the PICU, stepdown(SD) ICU, and acute care areas. Pre- and post-intervention metrics were assessed (pre-pandemic). Statistical Analysis: Process control charts were used to demonstrate the progression of mean asthma data from pre-intervention to post-intervention for percent order set utilization, lengths of stay (LOS), and modes of respiratory support. These metrics were compared using Welch’s t-tests with a significance level of 0.05. RESULTS  A total of 598 patients were analyzed pre-intervention and 304 patients post-intervention. Order set utilization significantly increased from 68 to 97% (p<0.001), PICU LOS decreased from 38.4 to 31.1 hours (p=0.013), SD ICU LOS decreased from 25.7 to 20.9 hours(p=0.01), and overall hospital LOS decreased from 59.5 to 50.7 hours (p=0.003). The LOS reduction resulted in overall hospital cost savings of $1,216,000 for the patient cohort. There were no differences in mode of respiratory support, mechanical ventilation, mortality rate, or readmission rate.    CONCLUSIONS  Implementation of a standardized RCP-driven electronic pathway for children with SA led to significantly increased order set utilization and decreased ICU and hospital lengths of stay.  Leveraging IT and standardized pathways for common diagnoses can lead to improved quality of care, outcomes, and cost savings. (04/2022)
  • Lopez M, Mathur M, Deming D, Tinsley C, Wilson M, Pascual M, & Abd-Allah S. (2012). IMPACT OF A QUALITY MEASURE CHECKLIST ON PATIENT CARE AND PROVIDER SATISFACTION IN A PEDIATRIC INTENSIVE CARE UNIT. Critical Care Medicine, 40(12), U177-U177. (12/2012)