Laryngoscopy for Neonatal and Infant Airway Management with Supplemental Oxygen at Different Flow Rates (OPTIMISE-2): A Multi-center, Non-inferiority, Prospective Randomized Controlled Trial

What this Trial Is About

This research aims to find the best oxygen flow rate during tracheal intubation using the C-MAC video laryngoscope with Miller or Macintosh blades in newborns and infants up to 52 weeks postconceptual age. The study focuses on whether low-flow supplemental oxygen differs significantly from high-flow oxygen during intubation in the operating room or intensive care unit. The goal is to see if both oxygen flow rates are similarly effective in managing the airway safely. Eligible children will be randomly assigned to receive either low-flow oxygen at 0.2 L/kg/min via nasal cannula or high-flow oxygen at 2 L/kg/min using the Optiflow device during intubation. All patients are pre-oxygenated before anesthesia induction and given muscle relaxants and sedatives according to protocol. Intubation is done orally or nasally with specified tube sizes based on the child's weight, using the C-MAC laryngoscope with blade sizes appropriate for their size. If intubation is difficult, specific protocols and devices will be used to secure the airway. Participants will be closely monitored with vital signs like oxygen saturation, heart rate, and blood pressure. Researchers will track success rates of first intubation attempts, number of attempts, time to intubate, oxygen levels, and any respiratory complications up to 24 hours post-intubation. The study includes careful assessments during and after intubation to evaluate airway management effectiveness and safety within 15 minutes of the procedure. Total participation covers the intubation procedure and immediate follow-up monitoring.

Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)