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Recruiting NCT06683599

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

Conditions: Difficult Airway, Difficult Airway Intubation, Neonate

Sex: All
Ages: 1 Minute – 52 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: Vinícius C Quintão, MD, MSc, PhD

Location: Perth Children's Hospital Perth Western Australia

Summary

Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06683599). StuddyBuddy aggregates publicly available trial information.