Failure of an effective physiologic threshold compliance tool to demonstrate benefit in a clinical trial of traumatic brain injury patients |
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| Institution: | 1. Department of Neurosurgery, Clinical Neurosciences Center, Clinical Neurosciences Center, University of Utah, USA;2. Section of Neurosurgery, University of Manitoba, Canada; Uniformed Services University, USA;1. Hospital Madre Teresa, Belo Horizonte, MG, Brazil;2. Hospital Municipal Miguel Couto, Rio de Janeiro, RJ, Brazil;3. University of Vanderbilt, School of Medicine, Nashville, TN, USA;4. Universidade Federal Fluminense, Rio de Janeiro, RJ, Brazil;1. Department of Neurosurgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea;2. Department of Neurosurgery, Ulsan Joong Ang Hospital, Ulsan, Republic of Korea;3. Department of Neurosurgery, Inje University Haeundae Paik Hospital, Busan, Republic of Korea;4. Department of Neurosurgery, Inje University Busan Paik Hospital, Busan, Republic of Korea;5. Department of Radiology, Inje University Busan Paik Hospital, Busan, Republic of Korea;6. Department of Neurology, Hanseo Hospital, Busan, Republic of Korea;7. Department of Neurosurgery, Kosin University Gospel Hospital, Busan, Republic of Korea;8. Department of Neurosurgery, Dongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea;1. Division of Neurosciences Critical Care, Department of Neurology, Neurosurgery, Anesthesiology and Critical Care Medicine and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States;2. Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States;1. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 510120 Guangzhou, Guangdong, China;2. Guangzhou University of Chinese Medicine, 510405 Guangzhou, Guangdong, China;3. University at Buffalo, The State University of New York, 14228 Buffalo, NY, USA;4. Guangxi University of Chinese Medicine, 530299 Nanning, Guangxi, China;5. The First Affiliated Hospital of Guangxi University of Chinese Medicine, 530023 Nanning, Guangxi, China;1. Neurosurgery Department, University Hospital S. Anna, Ferrara, Italy;2. Department of Translational Medicine, University of Ferrara, Ferrara, Italy |
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| Abstract: | BackgroundBetter physiologic threshold compliance holds promise for improving outcomes in neurocritical care patients.MethodsOur group developed a threshold compliance tool. This software computes and displays the proportion of values out of range in real time. We captured intracranial pressure (ICP) measures in our patients before and after implementation of this technology. Ten months after the threshold compliance tool was introduced we initiated a randomized controlled trial involving acute traumatic brain injury (TBI) patients to assess whether the tool was effective at reducing out-of-range ICP values.ResultsA total of 54 patients with ICP monitors were included in our analysis, 42 of whom sustained a TBI. Implementation of the threshold compliance tool was associated with an 85.3% reduction in ICP values exceeding 22 mmHg in neurocritical care patients (p = 0.004) and a 76.8% reduction in patients with TBI (p = 0.043). Out-of-range values in an area-under-the-curve analysis were reduced by 78.8% in all patients (p = 0.009) and in TBI patients by 77.9% (p = 0.051). Out-of-range values were not further reduced during our randomized controlled trial examining the threshold compliance tool, and a difference between treatment groups was not suggested.ConclusionsImplementation of a threshold compliance tool was associated with a marked and significant reduction in out-of-range ICP values. Benefit was, however, not evident in a randomized controlled trial. Our analysis provides a unique perspective on our failure to detect an apparent true difference and may provide insights into other neurotrauma trial failures. |
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| Keywords: | Threshold Neuromonitoring Intracranial pressure Compliance Head injury Traumatic brain injury Neurocritical care Technology Trial Failure |
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