Clinical Research Directory

AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients

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.

Risk of Pneumonia in Intubated Patients in Emergency Situations

Orotracheal intubation in emergency medicine is a vital procedure for ensuring adequate oxygenation and ventilation in patients with respiratory distress or in shock. However, this procedure exposes patients to complications such as pneumonia. In the matter of fact, the urgency of the procedure means that it is not possible to wait until the patient's stomach is empty. Pneumonia significantly increase patient morbidity and mortality. Therapeutic management must be early and appropriate to improve the patient's prognosis. The aim of this study is to compare the rate of pneumonia occurring in patients intubated in emergency situations with that in patients intubated in non-emergency situations in all 2024. Health data will only collected from patient's medical records.