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

RecruitingNAAges 1 Minute - 52 WeeksAllVinícius C Quintão, MD, MSc, PhD
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In plain words

What the trial is, and whether it could suit you

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 \<80% for over 60 seconds), although low

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📋 Eligibility rules (as published)
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.
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What it tests

  • Apneic oxygenation
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Where

4 sites
Perth Children's Hospital
Perth, Australia
Hospital das Clinicas HCFMUSP
São Paulo, Brazil
British Columbia Children's Hospital
Vancouver, Canada
Uppsala University Hospital
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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