Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial.

BACKGROUND: Pneumonia is the most common infection after out-of-hospital cardiac arrest (OHCA) occurring in up to 65% of patients who remain comatose after return of spontaneous circulation. Preventing infection after OHCA may (1) reduce exposure to broad-spectrum antibiotics, (2) prevent hemodynamic derangements due to local and systemic inflammation, and (3) prevent infection-associated morbidity and mortality. METHODS: The ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arrest (PROTECT) trial is a randomized, placebo-controlled, single-center, quadruple-blind (patient, treatment team, research team, outcome assessors), non-commercial, superiority trial to be conducted at Maine Medical Center in Portland, Maine, USA. Ceftriaxone 2 g intravenously every 12 h for 3 days will be compared with matching placebo. The primary efficacy outcome is incidence of early-onset pneumonia occurring < 4 days after mechanical ventilation initiation. Concurrently, T cell-mediated inflammation bacterial resistomes will be examined. Safety outcomes include incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea. The trial will enroll 120 subjects over approximately 3 to 4 years. DISCUSSION: The PROTECT trial is novel in its (1) inclusion of OHCA survivors regardless of initial heart rhythm, (2) use of a low-risk antibiotic available in the USA that has not previously been tested after OHCA, (3) inclusion of anti-inflammatory effects of ceftriaxone as a novel mechanism for improved clinical outcomes, and (4) complete metagenomic assessment of bacterial resistomes pre- and post-ceftriaxone prophylaxis. The long-term goal is to develop a definitive phase III trial powered for mortality or functional outcome. TRIAL REGISTRATION: ClinicalTrials.gov NCT04999592 . Registered on August 10, 2021.

Redesigning the Clinical Learning Environment to Improve Interprofessional Care and Education: Multi-Method Program Evaluation of the iPACE Pilot Unit.

BACKGROUND: In 2016, Maine Medical Center received an Accreditation Council for Graduate Medical Education Pursuing Excellence in Innovation grant to redesign the clinical learning environment to promote interprofessional care and education. The Interprofessional Partnership to Advance Care and Education (iPACE) model was developed and piloted on an adult inpatient medicine unit as an attempt achieve these aims. OBJECTIVE: We describe the iPACE model and associated outcomes. METHODS: Surveys and focus groups were employed as part of a multimethod pragmatic observational strategy. Team surveys included relational coordination (RC): a validated proprietary measure of interpersonal communication and relationships within teams. Pre-iPACE respondents were a representative historical sample from comparable inpatient medical units surveyed from March to April 2017. iPACE respondents were model participants surveyed March to August 2018 to allow for adequate sample size. RESULTS: Surveys were administered to pre-iPACE (N = 113, response rate 74%) and iPACE (N = 32, 54%) teams. Summary RC scores were significantly higher for iPACE respondents (iPACE 4.26 [SD 0.37] vs 3.72 [SD 0.44], P < .0001), and these respondents were also more likely to report a professionally rewarding experience (iPACE 4.4 [SD 0.6] vs 3.5 [SD 1.0], P < .0001). Learners felt the model was successful in teaching interprofessional best practices but were concerned it may hinder physician role development. Patient experience was positive. CONCLUSIONS: This pilot may have a positive effect on team functioning and team member professional experience and patient experience. Learner acceptance may be improved by increasing autonomy and preserving traditional learning venues.

A randomized prospective trial of the utility of rapid on-site evaluation of transbronchial needle aspirate specimens.

BACKGROUND: Previous studies have suggested an increased diagnostic yield for flexible bronchoscopic transbronchial needle aspirate (TBNA) specimens from lymph nodes when using rapid on-site evaluation by cytopathology but were limited by a lack of randomization, suggesting that selection bias may have contributed to its higher reported yield with TBNA. OBJECTIVES: The purpose of our study was to determine the effect of rapid on-site evaluation (ROSE) on the diagnostic power of TBNA. METHODS: The study is a prospective randomized controlled trial. Diagnoses made by procedures were recorded prospectively. The primary endpoint was diagnostic yield. RESULTS: Thirty-four patients were randomized to the ROSE group and 34 patients to the no-ROSE group. Specimen adequacy was 94% in the ROSE group and 88% in the no-ROSE group (P=0.67). The TBNA diagnostic yield was similar in both groups: ROSE, 55%; no-ROSE, 53% (P=1.000). Neoplastic diagnoses were made in 59% and 50% of ROSE and no-ROSE patients, respectively (P=0.63). There were no significant differences in the number of needle passes, procedure duration, or amount of sedatives used. There was a trend toward a decrease in the number of transbronchial biopsies needed in the ROSE group. CONCLUSIONS: Previous reports of increased diagnostic yield of ROSE were subject to selection bias. Routine use of ROSE in all TBNA procedures was not associated with a reduced procedure time or sedative use. ROSE may be beneficial by decreasing the need for transbronchial biopsy and the associated risk or if the probability of malignancy is likely. We recommend ROSE in selected patients over all TBNA procedures.

Methods of cooling: practical aspects of therapeutic temperature management.

OBJECTIVES: To review traditional and newer means of inducing, maintaining, and withdrawing therapeutic hypothermia and normothermia. To suggest treatment algorithms for temperature modulation and review neuromonitoring options. DESIGN: A review of current literature describing methods of performing therapeutic temperature management and neuromonitoring during the cooling, maintenance, and decooling periods. Algorithms for performing therapeutic temperature management are suggested. RESULTS: Temperature management can be safely and effectively performed using traditional or newer modalities. Although traditional means of cooling are feasible and efficacious, modern devices utilizing feedback loops to maintain steady body temperature and prevent overcooling have advantages in ease of application, patient safety, maintenance of target temperature, and control of decooling. Neuromonitoring options should be adapted to an individual patient and situation. CONCLUSIONS: Intensivists should be familiar with techniques to induce, maintain, and withdraw therapeutic temperature management, and select the most appropriate method for a given patient and situation.