Clinical trials

Background: Orotracheal intubation is an essential procedure in critically ill patients requiring ventilatory support, and the use of videolaryngoscopy is recommended as the gold standard in clinical practice. In recent years, the development of videolaryngoscopes through additive manufacturing has demonstrated lower production costs, and their integration with artificial intelligence (AI) has shown promising results in improving procedural success and safety. Aim: To evaluate the clinical performance and usability of a videolaryngoscope developed through additive manufacturing and integrated with artificial intelligence (AI) and computer vision, compared with a commercially available gold-standard videolaryngoscope. Methods: This is a multicenter, randomized, controlled, superiority Phase I/II clinical trial with a single-blind design. A total of 120 critically ill patients admitted to intensive care units at four hospitals in southern Brazil will be enrolled. Participants will be individually randomized in a 1:1 allocation ratio to parallel groups. The interventions will be performed by at least 10 physicians. All physicians will receive standardized training on device use, and procedures will be monitored by trained research staff. Data will be recorded in electronic Excel spreadsheets, and statistical analyses will be conducted using IBM SPSS Statistics. All ethical principles will be strictly observed, including obtaining informed consent from participants or their legal representatives. A Data and Safety Monitoring Committee will be established to oversee the study. Conclusions: If the expected results are confirmed, patients, healthcare professionals, and healthcare institutions may benefit from the improved performance, safety, and usability of the experimental device, particularly in critical care settings and public health emergencies.

The aquatic environment has characteristics that favor the adherence of older adults to exercise programs, and studies have shown that programs in this setting are effective in enhancing various aspects of physical fitness as well as cognitive function in this population. Research has explored whether incorporating cognitive tasks into an aquatic exercise program could offer additional benefits, but it remains uncertain whether this approach leads to greater improvements in cognitive function compared to aquatic exercises alone. The present protocol reports the WaterCog Study, which aims to evaluate the effects of an aquatic aerobic exercise program combined with cognitive tasks, compared to a conventional aquatic aerobic exercise program and a control group, on cognitive function and other health-related outcomes in older adults. This trial is a randomized, single-blinded, three-arm, parallel, superiority trial. A total of 98 older adults are randomized into one of three groups: 1) an aquatic aerobic exercise program combined with cognitive tasks, 2) a conventional aquatic aerobic exercise program, and 3) a control group. Participants in both exercise groups complete a 12-week exercise program with two weekly sessions on non-consecutive days. The primary outcome is cognitive function, while secondary outcomes include physical function, cardiovascular, and psychosocial parameters. Outcomes are measured at baseline, post-intervention, and at the 12-week follow-up after the end of the intervention period. The analysis plan will employ an intention-to-treat approach and per-protocol criteria. The conceptual hypothesis of the study is that both training programs will significantly improve the investigated outcomes compared to the control group. Additionally, it is expected that aquatic exercises with cognitive tasks will promote additional benefits in cognitive function, with similar gains in physical function, cardiovascular, and psychosocial parameters compared to conventional aquatic aerobic exercises in post-intervention and follow-up measures.

The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.