Trials
-
Randomized Controlled Trial Multicenter Study Comparative Study
Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial.
China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that laser peripheral iridotomy (LPI) alone is not sufficient to prevent disease progression. Laser peripheral iridoplasty (LPIP) is an alternative and effective way of widening the angle recess in eyes that are affected by primary angle closure (PAC). However, it is not known if greater benefit would be achieved using LPI plus LPIP for PAC with multiple mechanisms (MAC). Thus, the aim of this study is to demonstrate if LPI plus LPIP would be more effective than single LPI in controlling the progression of PAC with multiple mechanisms, based on ultrasound biomicroscopy (UBM) classification. A secondary aim is to determine whether or not this would result in the use of less medication and/or prolong the time to antiglaucoma surgery. ⋯ If the LPI plus LPIP is found to significantly decrease the rate of PAC progression, this intervention could potentially be a standard therapy to be used to treat PAC when multiple mechanisms are involved in angle closure. Subsequently, this would have the potential to delay the rate of PAC progression to PACG and delay the time to the administration of antiglaucoma medication or trabeculectomy surgery.
-
Randomized Controlled Trial Multicenter Study
Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial.
Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia. ⋯ This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail.
-
Randomized Controlled Trial Pragmatic Clinical Trial
Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial.
Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown. ⋯ This ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults.
-
Randomized Controlled Trial
Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial.
Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary (TV bound), thus not enabling PA anywhere and at any time, we developed a smartphone-based, game-like software application (MOBIGAME) specifically designed for middle-aged T2DM patients to induce a healthier, more active lifestyle as part of successful T2DM treatment and management. In a randomized controlled trial we aim to examine whether our smartphone-based game application can lead to increases in daily PA in T2DM patients that are persistent in the mid to long term and whether these increases are greater than those in a control group. ⋯ This research will investigate the effectiveness of a novel smartphone-based, game-like software application to be used as a way to promote regular daily PA among inactive T2DM patients. The results of this trial may have important implications for future PA-promoting interventions and provide relevant information for the general transferability of such applications to be used as part of the treatment in other chronic diseases.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study.
Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy. ⋯ This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures.