Infant, Intubation Complication
Conditions
Keywords
Infant, Intubation, NICU, Safety
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.
Interventions
OTHERPersonalized 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
Sponsors
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
Exclusion criteria
Endotracheal tube exchanges, as this represents a distinct procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracheal intubation associated event (TIAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Severe TIAE | During the intubation procedure, on average 20 minutes | Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions |
| Magnitude of oxygen desaturation | During the intubation procedure, on average 20 minutes | Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure |
| Number of subjects with multiple intubation attempts (>2 attempts) | During the intubation procedure, on average 20 minutes | More than 2 intubation attempts |
| Duration of mechanical ventilation | Through study completion, on average 90 days | Duration of mechanical ventilation after the immediate intubation encounter |
| Number of subjects requiring reintubation within 24 hours of extubation | Up to 24 hours after extubation | Need for reintubation within 24 hours of extubation from the course of ventilation immediately following the intubation encounter |
| Number of subjects with Intraventricular hemorrhage | Up to 7 days after birth | Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants |
| NICU Mortality | Through study completion, on average 90 days | Death before NICU discharge |
Countries
Canada, United States
Contacts
CONTACTElizabeth Foglia, MD
CONTACTHayley Buffman, MPH
PRINCIPAL_INVESTIGATORElizabeth Foglia, MD
Children's Hospital of Philadelphia
Outcome results
None listed