SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation

Launched by VINÍCIUS C QUINTÃO, MD, MSC, PHD · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help safely place breathing tubes (intubation) in newborns and infants, especially when they have difficulty breathing. Intubation is a critical procedure that can save lives, but it can be tricky, and many babies experience drops in oxygen levels during the process. The researchers want to see if using special tools (called video laryngoscopes) along with extra oxygen can make it easier to intubate these young patients and reduce the risks associated with low oxygen levels.

To participate in this study, babies and infants up to 52 weeks old who need a breathing tube for reasons like surgery or medical treatment could be eligible. However, those who have had challenges with intubation before or who need different methods to secure their airway may not qualify. If enrolled, participants will receive the procedure in a controlled setting, and the research team will closely monitor their progress to ensure their safety. This study aims to improve how we manage breathing difficulties in our youngest patients, making the process safer and more effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.
• • Neonates and infants up to 52 weeks post-conceptual age.
• • Written informed consent provided by legal guardians prior to the intervention.
• Exclusion Criteria:
• • Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
• • Requirement for an alternative technique to direct laryngoscopy to secure the airway.
• • Specific conditions, such as congenital heart disease requiring FiO₂ \< 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.