Browsing by Author "Limkakeng, AT"
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Item Open Access Critical Care Air Transport Team severe traumatic brain injury short-term outcomes during flight for Operation Iraqi Freedom/Operation Enduring Freedom.(Journal of the Royal Army Medical Corps, 2017-10) Boyd, L Renee; Borawski, J; Lairet, J; Limkakeng, ATOur understanding of the expertise and equipment required to air transport injured soldiers with severe traumatic brain injuries (TBIs) continue to evolve.We conducted a retrospective chart review of characteristics, interventions required and short-term outcomes of patients with severe TBI managed by the US Air Force Critical Care Air Transport Teams (CCATTs) deployed in support of Operation Iraqi Freedom and Operation Enduring Freedom between 1 June 2007 and 31 August 2010. Patients were cared for based on guidelines given by the Brain Trauma Foundation and the Joint Theater Trauma System by non-neurosurgeon physicians with dedicated neurocritical care training. We report basic characteristics, injuries, interventions required and complications during transport.Intracranial haemorrhage was the most common diagnosis in this cohort. Most injuries were weapon related. During this study, there were no reported in-flight deaths. The majority of patients were mechanically ventilated. There were 45 patients who required at least one vasopressor to maintain adequate tissue perfusion, including four patients who required three or more. Some patients required intracranial pressure (ICP) management, treatment of diabetes insipidus and/or seizure prophylaxis medications.Air transport personnel must be prepared to provide standard critical care but also care specific to TBIs, including ICP control and management of diabetes insipidus. Although these patients and their potential complications are traditionally managed by neurosurgeons, those providers without neurosurgical backgrounds can be provided this training to help fill a wartime need. This study provides data for the future development of air transport guidelines for validating and clearing flight surgeons.Item Open Access Trial design for assessing analytical and clinical performance of high-sensitivity cardiac troponin I assays in the United States: The HIGH-US study.(Contemporary clinical trials communications, 2019-06) Christenson, RH; Peacock, WF; Apple, FS; Limkakeng, AT; Nowak, RM; McCord, J; deFilippi, CRBackground:High-sensitivity cardiac troponin I (hs-cTnI) assays have been developed that quantify lower cTnI concentrations with better precision versus earlier generation assays. hs-cTnI assays allow improved clinical utility for diagnosis and risk stratification in patients presenting to the emergency department with suspected acute myocardial infarction. We describe the High-Sensitivity Cardiac Troponin I Assays in the United States (HIGH-US) study design used to conduct studies for characterizing the analytical and clinical performance of hs-cTnI assays, as required by the US Food and Drug Administration for a 510(k) clearance application. This study was non-interventional and therefore it was not registered at clinicaltrials.gov. Methods:We conducted analytic studies utilizing Clinical and Laboratory Standards Institute guidance that included limit of blank, limit of detection, limit of quantitation, linearity, within-run and between run imprecision and reproducibility as well as potential interferences and high dose hook effect. A sample set collected from healthy females and males was used to determine the overall and sex-specific cTnI 99th percentile upper reference limits (URL). The total coefficient of variation at the female 99th percentile URL and a universally available American Association for Clinical Chemistry sample set (AACC Universal Sample Bank) from healthy females and males was used to examine high-sensitivity (hs) performance of the cTnI assays. Clinical diagnosis of enrolled subjects was adjudicated by expert cardiologists and emergency medicine physicians. Assessment of temporal diagnostic accuracy including sensitivity, specificity, positive predictive value, and negative predictive value were determined at presentation and collection times thereafter. The prognostic performance at one-year after presentation to the emergency department was also performed. This design is appropriate to describe analytical characterization and clinical performance, and allows for acute myocardial infarction diagnosis and risk assessment.