Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Conditions
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Infant, Intubation Complication

Intervention / Treatment
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* Other: Personalized Intubation Safety (PINS) Bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU) Exclusion Criteria: Endotracheal tube exchanges, as this represents a distinct procedure.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Intervention Phase<br>NICU Patients who are intubated without the PINS Bundle. | |
| Active Comparator: Post-intervention Phase<br>NICU Patients who are intubated after unit implementation of the PINS Bundle | Other: Personalized Intubation Safety (PINS) Bundle<br>* 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<br>* Other names: PINS Bundle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal intubation associated event (TIAE) | 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 | During the intubation procedure, on average 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe TIAE | Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions | During the intubation procedure, on average 20 minutes | 
| Magnitude of oxygen desaturation | Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure | During the intubation procedure, on average 20 minutes | 
| Number of subjects with multiple intubation attempts (>2 attempts) | More than 2 intubation attempts | During the intubation procedure, on average 20 minutes | 
| Duration of mechanical ventilation | Duration of mechanical ventilation after the immediate intubation encounter | Through study completion, on average 90 days | 
| Number of subjects requiring reintubation within 24 hours of extubation | Need for reintubation within 24 hours of extubation from the course of ventilation immediately following the intubation encounter | Up to 24 hours after extubation | 
| Number of subjects with Intraventricular hemorrhage | Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants | Up to 7 days after birth | 
| NICU Mortality | Death before NICU discharge | Through study completion, on average 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Intubation, NICU, Safety