Articles: outcome.
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Comment Multicenter Study Comparative Study Pragmatic Clinical Trial
Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial.
Blood transfusions are commonly administered to patients with acute brain injury. The optimal hemoglobin transfusion threshold is uncertain in this patient population. ⋯ Patients with acute brain injury and anemia randomized to a liberal transfusion strategy were less likely to have an unfavorable neurological outcome than those randomized to a restrictive strategy.
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Although medical devices are widely used in clinical practice, clinicians and the public have limited access to information on how devices are tested, regulated, and used, posing challenges to patient safety. This article uses Cook Medical's Celect inferior vena cava (IVC) filter, a medical device used for prevention of pulmonary embolism, as a case study of the transparency gap in medical device regulation. Recently unsealed court documents from litigation related to Celect reveal that the device's clinical study protocol did not follow U. ⋯ Food and Drug Administration (FDA) guidance for IVC filter testing and that study outcome definitions for IVC perforation had lower sensitivity for detecting adverse events than those recommended by professional societies. Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in the published literature and on the device label, providing patients and clinicians with inaccurate information about the device's safety. The Celect IVC filter case demonstrates the need for regulatory reforms to ensure that critical safety data are accessible to the FDA, clinicians, and patients to inform decision making.
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J Neurosurg Anesthesiol · Nov 2024
Intraoperative Burst Suppression by Analysis of Raw Electroencephalogram Postoperative Delirium in Older Adults Undergoing Spine Surgery: A Retrospective Cohort Study.
Postoperative delirium is a common complication in older adults, associated with poor outcomes, morbidity, mortality, and higher health care costs. Older age is a strong predictor of delirium. Intraoperative burst suppression on the electroencephalogram (EEG) has also been linked to postoperative delirium and poor neurocognitive outcomes. ⋯ Intraoperative burst suppression identified by visual analysis of the EEG was more strongly associated with delirium than age in older adults undergoing spine surgery. Further research is needed to determine the clinical importance of these findings.
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Curr Opin Crit Care · Nov 2024
How to protect the diaphragm and the lung with diaphragm neurostimulation.
In the current review, we aim to highlight the evolving evidence on using diaphragm neurostimulation to develop lung and diaphragm protective mechanical ventilation. ⋯ Scientific interest in temporary diaphragm neurostimulation has dramatically evolved in the last few years. Despite a solid physiological rationale and promising preliminary findings confirming a beneficial effect on the diaphragm and lungs, more studies and further technological advances will be needed to establish optimal standardized settings and lead to clinical implementation and improved outcomes.