NCT06683599 SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
| NCT ID | NCT06683599 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vinícius C Quintão, MD, MSc, PhD |
| Condition | Difficult Airway |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2026-06-01 |
Trial Parameters
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Brief 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.
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.