NCT05838690

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.

Detailed description

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.

Conditions

• Infant
• Intubation Complication

Interventions

Type	Name	Description
OTHER	Personalized Intubation Safety (PINS) Bundle	The Personalized Intubation Safety (PINS) Bundle addresses 5 core domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary intubation plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic premedication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan

Timeline

• Start date: 2023-04-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2023-05-01
• Last updated: 2026-03-04

Locations

8 sites across 2 countries: United States, Canada