Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Overview
- Phase
- Not Applicable
- Intervention
- Pre-Intervention Phase
- Conditions
- Infant
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 3000
- Locations
- 8
- Primary Endpoint
- Tracheal intubation associated event (TIAE)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
Exclusion Criteria
- •Endotracheal tube exchanges, as this represents a distinct procedure.
Arms & Interventions
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
Intervention: Personalized Intubation Safety (PINS) Bundle
Outcomes
Primary Outcomes
Tracheal intubation associated event (TIAE)
Time Frame: 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
Secondary Outcomes
- 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)