Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides® Refraint® (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints. Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides® safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT). Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Exersides® and traditional wrist restraints for 4 h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides® safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., ⩾90% of required data collected), and patient/family/clinician feedback. Results: Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Exersides®, averaging (SD) 2.5 (1.0) hours per session, with no safety events reported. Across restraint time periods, 92% and 100% of Richmond Agitation-Sedation Scale (RASS) and wrist actigraphy data, respectively, were collected. Feedback was positive (more movement and comfortable than traditional restraints) and constructive (bulky, intimidating to apply). Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.
Edited by Pamela Douglas, MD W. B. Saunders, 2002Cardiovascular disease is the leading cause of death for women in the United States. Furthermore, as the average age of the American woman increases, the morbidity and mortality rates of cardiovascular disease are likely to increase dramatically. Until recently, it was thought that the clinical manifestations of women with cardiovascular disease were essentially similar to those of men and warranted similar management. Researchers conducted their studies predominantly on men, and when they included women, their numbers were usually too small to allow for extensive observations of possible gender differences. The past decade has seen a dramatic increase in the number of women enrolled in clinical studies, in part due to the initiative of the National Institutes of Health and of clinician scientists trained in cardiovascular medicine.The second edition of Cardiovascular Health and Disease in Women, edited by Pamela Douglas, MD, brings together many clinicians and scientists prominent in the field of women's cardiovascular health. The book is divided into 6 sections and covers a wide range of topics, including clinical approaches, prevention, clinical coronary heart disease, and cardiovascular issues in pregnancy.One section is also devoted to hormones and heart disease. Unfortunately, the results of the Heart and Estrogen/ Progestin Replacement Study (HER II) and the Women's Health Initiative (WHI) came to light only after this text was published. However, all the chapters are well written and provide the clinical physician with a comprehensive and readable explanation of the effects of estrogen and progesterone on the cardiovascular system. The chapters in this section remain relevant in that they provide background for the mechanisms of estrogen/ progesterone on the vascular system and include a thorough review of the clinical studies leading up to HER II and WHI.The section on coronary heart disease risk and prevention is comprehensive and well written. Separate chapters on lipids, diabetes, hypertension, and other risk factors balance a review of past clinical studies with a discussion of current guidelines and practice management. Both internists and specialty physicians, such as cardiologists, will find this section helpful both for their own review and as a guide to patient care.The section on clinical coronary heart disease (CHD) is also well written and features well-known authors. The topics covered are divided into clinically relevant areas, such as chronic stable angina and acute coronary syndromes (ACS). Unfortunately, the constantly changing practices for treatment of ACS make some of the studies cited in this text out of date. The chapter on diagnostic testing is excellent. The discussion of pretest and posttest probability is thorough and cites examples to clarify the risks for women who either have or may have CHD. The chapter on implementing strategies for the secondary prevention of coronary heart disease is also very well written and provides an e...
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