Real-World Experience on Why Research Flatlines: A Review of Trials From the Coordinator's Perspective.

INTRODUCTION: Investigator-initiated research trial failure is a national concern that hinders the dissemination of information while wasting resources, time, and funding. The goal of this analysis was to provide an objective review of points to consider increasing an investigator's chances of success. METHODS: The included trials were divided into two groups based on whether they were successful or unsuccessful in meeting enrollment goals. Common issues were noted for each trial to identify prevalent issues and compare their quantity within each group. RESULTS: Unsuccessful trials averaged twice as many issues as trials in the successful group. The most common problems identified in unsuccessful studies involved study planning, whereas the most common problems identified in successful studies revolved around study staff. CONCLUSIONS: There is no single definitive indicator for trial failure; however, awareness of these issues in a trial's planning phase can help prevent their occurrence and aid in overall completion and publication.

Dosing Cefazolin for Surgical Site Infection Prophylaxis in Adolescent Idiopathic Scoliosis Surgery: Intermittent Bolus or Continuous Infusion?-A Pilot Study.

Background: Cefazolin may minimize the risk of surgical site infection (SSI) following posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS). Cefazolin dosing recommendations vary and there is limited evidence for achieved tissue concentrations. Methods: We performed a randomized, controlled, prospective pharmacokinetic pilot study of 12 patients given cefazolin by either intermittent bolus (30 mg/kg every 3 h) or continuous infusion (30 mg/kg bolus followed by 10/mg/kg per hour) during PSF for AIS. Results: Patients were well matched for demographic and perioperative variables. While total drug exposure, measured as area-under-the-curve (AUC), was similar in plasma for bolus and infusion dosing, infusion dosing achieved greater cefazolin exposure in subcutaneous and muscle tissue. Using the pharmacodynamic metric of time spent above minimal inhibitory concentration (MIC), both bolus and infusion dosing performed well. However, when targeting a bactericidal concentration of 32 µg/mL, patients in the bolus group spent a median of 1/5 and 1/3 of the typical 6 h operative time below target in subcutaneous and muscle tissue, respectively. Conclusions: We conclude that intraoperative determination of cefazolin tissue concentrations is feasible and both bolus and infusion dosing of cefazolin achieve concentrations in excess of typical MICs. Infusion dosing appears to more consistently achieve bactericidal concentrations in subcutaneous and muscle tissues.

Incidence of acute compartment syndrome with routine use of regional anesthesia for patients with long bone fractures: a large single-center retrospective review from a level I trauma tertiary academic institution.

INTRODUCTION: Traditionally, using peripheral nerve blocks (PNBs) in patients with long bone fractures has been limited due to concerns that it may interfere with the timely diagnosis of acute compartment syndrome (ACS). However, our large academic institution and level I trauma center have been using regional anesthesia routinely for pain management of patients with long bone fractures for more than a decade, with strict adherence to a comprehensive management protocol. The aim of this retrospective review is to present our experience with this practice. METHODS: Following Institutional Review Board approval, we performed a retrospective chart review of patients with long bone fractures and ACS over a 10-year period (2008-2018). RESULTS: 26 537 patients were included in the review. Approximately 20% of these patients required surgery, and 91.5% of surgically treated patients received regional anesthesia. The incidence of ACS in our cohort was 0.1% or 1.017 per 1000 patients with long bone fractures. CONCLUSION: Current recommendations on using PNBs in patients at risk for ACS have been mainly based on expert opinion and dated case reports. Due to the nature of the condition, prospective data are lacking. Our large observational dataset evaluated the risk of missing or delaying ACS diagnosis when PNBs were offered for trauma patients and demonstrated a relatively low incidence of ACS despite the routine use of PNBs under strictly protocolized conditions when patients were managed by a dedicated multidisciplinary care team.

Staying proper with your personal protective equipment: How to don and doff.

INTRODUCTION: The global COVID-19 pandemic highlighted the importance of protecting frontline healthcare workers from novel respiratory infections while also exposing the limited instruction that medical students receive on proper donning of personal protective equipment (PPE) and more importantly the safe doffing of contaminated PPE to minimize their risk of nosocomial infection. The best methods of providing this kind of instruction have not yet been determined. METHODS: Anesthesiology interns and CA-1 residents were trained on proper PPE donning and doffing for AGPs using a methodology based on Miller's pyramid and following a "knows-knows how-shows-does" progression. Participants donned PPE without instruction and were sprayed with Glo Germ® to identify areas of contamination, after which they received both video and in-person instruction on best practices for donning and doffing PPE for AGPs. Following instruction, they again donned PPE and were sprayed with Glo Germ® to identify areas of contamination. RESULTS: 54 participants completed the study. Before training, overall donning compliance was 60% and overall doffing compliance was 48%. Overall, 70% were contaminated after PPE doffing, with 46% having multiple sites of contamination. After training, donning compliance increased by nearly 30% (P < 0.001), doffing compliance increased by over 20% (P < 0.001), and overall contamination decreased by nearly 30% (P = 0.029), with multiple-site contamination decreasing to only 6% (P = 0.013). DISCUSSION: While best methods for providing instruction regarding topics such as PPE donning and doffing have not yet been determined, we have demonstrated that the underlying knowledge base from medical school regarding proper donning and doffing for respiratory isolation is insufficient for preventing self-contamination, and that Miller's pyramid-based training using both video and in-person instruction combined with task execution by learners can improve compliance with PPE donning and doffing protocols and more importantly decrease skin contamination among a group of early training anesthesiology residents.

Genetically Confirmed Malignant Hyperthermia in a Six-Week-Old Infant: A Case Report.

A six-week-old 3.9-kg infant presented for microlaryngoscopy and diaphragmatic hernia repair. While positioning for laparoscopy after microlaryngoscopy, the infant developed muscle rigidity, worsening hypercarbia, tachycardia, and early hyperthermia. Sevoflurane was discontinued, and the clinical picture indicating malignant hyperthermia (MH) resolved without dantrolene. Subsequent genetic testing revealed that both the patient and his father carried a mutation in the RYR1 gene that is diagnostic for MH. This is the second youngest genetically confirmed case of MH. This case adds to a limited body of evidence regarding MH presentation and diagnosis in neonates and infants.

Role of an Intercostobrachial Nerve Block in Alleviating Tourniquet Pain: A Randomized Clinical Trial.

Introduction Tourniquet pain may have cutaneous and ischemic components. It is questionable whether blockade of a sensory nerve will help reduce ischemic pain. In addition, complete anesthesia of the axilla in the intercostobrachial nerve (ICBN) distribution is challenging to execute, and ICBN blockade has an inherently higher failure rate because of its variable anatomic location and source of innervation. We sought to determine the utility of an ICBN block for the prevention of tourniquet pain. Methods We conducted a single-center randomized controlled trial at a major academic medical center involving patients scheduled to undergo distal upper extremity surgery under ultrasound-guided supraclavicular brachial plexus block. Forty patients were randomized to receive an additional ICBN block or no ICBN block, with 22 allocated to the intervention and 18 to control. We collected data on the incidence of tourniquet pain and systemic anesthetic requirements. Results Initial contingency analysis examining the relationship between ICBN block placement and the development of pain using the two-tailed Fisher exact test failed to show that the presence or absence of ICBN block was associated with the development of tourniquet pain. χ2 analysis failed to show that tourniquet time was significantly related to the development of tourniquet pain. Conclusions The overall incidence of tourniquet pain in the setting of a dense supraclavicular brachial plexus block for surgical anesthesia was low even without an ICBN block and even with tourniquet times greater than 90 min. Tourniquet pain was easily managed with small amounts of systemic analgesics.