Clinical Research Directory

Pilot Study on the Use of Video Laryngoscopy in Pre-hospital Settings

Management of the upper airways is an essential skill in pre-hospital medicine in order to protect the respiratory tract and optimise ventilation and oxygenation. Orotracheal intubation remains the gold standard method in this context. In France, approximately 8% of primary SMUR interventions require intubation, representing 40,000 to 50,000 procedures per year, 30 to 40% of which are performed on patients in cardiorespiratory arrest. Despite an overall success rate of nearly 99%, 8 to 15% of intubations are considered difficult and the success rate on the first attempt is only 77.8%. Difficult intubations expose patients to significant complications, including desaturation (nearly 50% of cases), haemodynamic disorders and, more rarely, cardiopulmonary arrest (3% of cases). Pre-hospital conditions (environment, access to the patient, trauma, secretions, etc.) increase these risks. As a result, recent recommendations now consider any emergency intubation outside the operating theatre to be potentially difficult. The introduction of video laryngoscopy represents a major technological advance. Its superiority has been demonstrated in hospital settings, particularly for difficult intubations, and it is now recommended as the first-line treatment in this context. However, unlike in the United States, where several studies suggest that it is safer and more effective than direct laryngoscopy, there are no specific recommendations or French studies concerning its use in pre-hospital medicine. Given these factors and the lack of national data, it seems appropriate to conduct an exploratory French study to assess the place, effectiveness, benefits and constraints of video laryngoscopy in a pre-hospital setting. Investigator hypothesises that the success rate for the first attempt at intubation using video laryngoscopy will be 74%.

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.