SEALion: Effectiveness of Nasal Cannula Supplemental Oxygen During Intubation in Neonates and Infants

What this Trial Is About

Neonates and infants up to 52 weeks post-conceptual age who require tracheal intubation are the focus of this study, which evaluates supplemental oxygen delivered via nasal cannula during intubation using video laryngoscopy. The study aims to improve the first-attempt success rate of intubation and reduce adverse events such as severe desaturation, which can lead to serious complications like hypoxic encephalopathy, cardiac arrest, or death. These risks are higher in neonates due to their unique respiratory physiology and susceptibility to rapid oxygen desaturation under anesthesia and paralysis. Participants will be randomized to receive either apneic oxygenation with 1 L/kg/min FiO2 1.0 low-flow oxygen via a conventional nasal cannula during intubation or standard care without apneic oxygenation. Intubation will be performed using a video laryngoscope with either a Miller or Macintosh blade size 0 or 1 in operating rooms or intensive care units. The study includes detailed anesthesia induction protocols, tube size selection based on weight and age, and careful monitoring of neuromuscular blockade, with up to four intubation attempts allowed following a difficult airway algorithm if needed. During the study, participants will have continuous monitoring of oxygen saturation, heart rate, and blood pressure. Researchers will track the first-attempt success rate, desaturation rates, number of intubation attempts, time to intubation, respiratory complications within 24 hours, and other airway assessment scores. Safety and effectiveness will be evaluated up to 15 minutes after randomization, with some measures taken up to 24 hours. The total participation time and detailed procedural steps aim to ensure safety while assessing the impact of supplemental oxygen during neonatal intubation.

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