Scientific reports
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Randomized Controlled Trial
Transnasal humidified rapid insufflation ventilatory exchange vs. facemask oxygenation in elderly patients undergoing general anaesthesia: a randomized controlled trial.
Transnasal humidified rapid insufflation ventilator exchange (THRIVE) may be effective in delaying hypoxia, but the efficacy of THRIVE for oxygenation in elderly patients under general anaesthesia has not been assessed. This study assessed whether THRIVE prolonged the apnoea time in the elderly patients after induction. This was a single centre, two-group, randomized controlled trial. 60 patients (65 to 80 years of age) with American Society of Anesthesiologists (ASA) grades I ~ III who required tracheal intubation or the application of a laryngeal mask under general anaesthesia were randomly allocated to receive oxygenation using THRIVE (100% oxygen, 30~70 litres min-1) or a facemask (100% oxygen, 10 litres min-1) during the pre-oxygenation period and during apnoea. ⋯ No increased occurrence of complications, including haemodynamic instability, resistant arrhythmia or nasal discomfort, were reported in both the THRIVE group and the facemask group. THRIVE prolongs the apnoea time in elderly patients. THRIVE may be a more effective method for pre-oxygenation than a facemask in the elderly without pulmonary dysfunction.
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Randomized Controlled Trial
A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.
External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. ⋯ There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.
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Randomized Controlled Trial Comparative Study
Inhaled milrinone in cardiac surgical patients: a pilot randomized controlled trial of jet vs. mesh nebulization.
Inhaled milrinone administered before cardiopulmonary bypass (CPB) reduces the severity of pulmonary hypertension during cardiac surgery. However, milrinone pharmacokinetics has not been determined for this route of administration. The objective of this study was to investigate inhaled milrinone dosing in vitro and early plasma concentrations in vivo after jet and mesh nebulization. ⋯ Consistent with this, the early plasma concentrations in vivo were also 2-3 fold higher after mesh nebulization (P = 0.002-0.005). After inhalation (jet or mesh nebulization), milrinone early plasma concentrations remained within the therapeutic range. No systemic hypotension was reported in our patients.
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Randomized Controlled Trial
Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).
Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. ⋯ Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit Ist compared to visit IIIrd) and suprailiac skinfold (visit IInd compared to visit IIIrd) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.
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Randomized Controlled Trial Multicenter Study
An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial.
The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). ⋯ The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.