Optimizing Tracheal Intubation Outcomes and Neonatal Safety with the Personalized Intubation Safety (PINS) Bundle

What this Trial Is About

The trial investigates the impact of a personalized intubation planning tool called the Personalized INtubation Safety (PINS) Bundle on the safety and clinical outcomes of infants undergoing tracheal intubation in the neonatal intensive care unit (NICU). This study aims to reduce adverse events that often occur during intubation, such as complications, multiple attempts, and oxygen desaturation. It compares outcomes with and without the use of the PINS Bundle in a pragmatic stepped wedge cluster randomized design across 8 hospitals. The PINS Bundle is designed to create a personalized and multidisciplinary intubation plan based on five key domains: patient risk assessment, treatment threshold for intubation, use of premedication (favoring paralytic drugs), choice of equipment (promoting video laryngoscope use), and provider selection with escalation plans. The study includes two groups of NICU patients: those intubated before PINS Bundle implementation and those intubated after its adoption. Participants are infants up to 1 year old who require tracheal intubation in the NICU. Researchers will monitor intubation-associated events during procedures lasting about 20 minutes, including severe events, oxygen desaturation, and multiple attempts. They will also track clinical outcomes like duration of mechanical ventilation, reintubation within 24 hours, intraventricular hemorrhage up to 7 days after birth, and NICU mortality over about 90 days. The trial is sponsored by the Children's Hospital of Philadelphia and began in April 2023, continuing until the end of 2027.

Optimizing Tracheal Intubation Outcomes and Neonatal Safety