Optimizing Tracheal Intubation Outcomes and Neonatal Safety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 8
- 主要终点
- Tracheal intubation associated event (TIAE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
排除标准
- •Endotracheal tube exchanges, as this represents a distinct procedure.
研究组 & 干预措施
Pre-Intervention Phase
NICU Patients who are intubated without the PINS Bundle.
Post-intervention Phase
NICU Patients who are intubated after unit implementation of the PINS Bundle
干预措施: Personalized Intubation Safety (PINS) Bundle (Other)
结局指标
主要结局
Tracheal intubation associated event (TIAE)
时间窗: During the intubation procedure, on average 20 minutes
Any adverse tracheal intubation associated event (TIAE) during the intubation encounter. In NEAR4NEOS database, a comprehensive group of adverse TIAEs are based on standard consensus-based definitions and classified as severe and non-severe
次要结局
- Magnitude of oxygen desaturation(During the intubation procedure, on average 20 minutes)
- Duration of mechanical ventilation(Through study completion, on average 90 days)
- Number of subjects requiring reintubation within 24 hours of extubation(Up to 24 hours after extubation)
- Severe TIAE(During the intubation procedure, on average 20 minutes)
- Number of subjects with Intraventricular hemorrhage(Up to 7 days after birth)
- Number of subjects with multiple intubation attempts (>2 attempts)(During the intubation procedure, on average 20 minutes)
- NICU Mortality(Through study completion, on average 90 days)