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SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
Sponsor: Vinícius C Quintão, MD, MSc, PhD
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 \<80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time. This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.
Official title: SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula
Key Details
Gender
All
Age Range
1 Minute - 52 Weeks
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-12-10
Completion Date
2026-12-01
Last Updated
2025-11-25
Healthy Volunteers
No
Interventions
Apneic oxygenation
1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.
Locations (3)
Perth Children's Hospital
Perth, Western Australia, Australia
Hospital das Clinicas HCFMUSP
São Paulo, Brazil
Uppsala University Hospital
Uppsala, Sweden