Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Tracheal intubation (TI) in the neonatal intensive care unit (NICU) is frequently complicated by adverse safety outcomes such as adverse tracheal intubation associated events, multiple TI attempts, and oxygen desaturation. Investigators have developed, refined, and tested a Personalized INtubation Safety (PINS) Bundle that targets a prospective and individualized approach to TI planning and management. The Prospective Intubation Safety (PINS) Bundle addresses 5 core evidence-based domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary TI plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic medication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan.

This is a pragmatic stepped wedge cluster randomized trial of NICU patients who are intubated across 8 participating hospitals to determine if the PINS Bundle, compared to no PINS Bundle, reduces the incidence of adverse tracheal intubation associated events.

The primary objective of this study is to determine the effectiveness of the PINS Bundle to decrease adverse TI safety events. The secondary objectives are 1) to evaluate if the impact of the PINS Bundle on adverse TI safety events varies based on provider skill, and 2) to determine the impact of the PINS Bundle on NICU clinical outcomes of extubation failure, duration of intubation, NICU mortality, and intraventricular hemorrhage.

• Severe TIAE [Срок оценки: During the intubation procedure, on average 20 minutes]
• Magnitude of oxygen desaturation [Срок оценки: During the intubation procedure, on average 20 minutes]
• Number of subjects with multiple intubation attempts (>2 attempts) [Срок оценки: During the intubation procedure, on average 20 minutes]
• Duration of mechanical ventilation [Срок оценки: Through study completion, on average 90 days]
• Number of subjects requiring reintubation within 24 hours of extubation [Срок оценки: Up to 24 hours after extubation]
• Number of subjects with Intraventricular hemorrhage [Срок оценки: Up to 7 days after birth]
• NICU Mortality [Срок оценки: Through study completion, on average 90 days]