Clinical Research Directory

Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment

Sponsor: University of Sao Paulo General Hospital

Summary

The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device. The main questions this study aims to answer are: Is the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants? Are there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs? Researchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other. Participants will: Be randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes; Receive standard general anesthesia for an elective surgical procedure; Have information collected during and after the procedure to assess safety, effectiveness, and costs.

Official title: Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial

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