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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,000
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
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGUniversity of Colorado - Denver
Denver, Colorado, United States
RECRUITINGYale-New Haven Hospital
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
Time frame: During the intubation procedure, on average 20 minutes
Severe TIAE
Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions
Time frame: 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
Time frame: During the intubation procedure, on average 20 minutes
Number of subjects with multiple intubation attempts (>2 attempts)
More than 2 intubation attempts
Time frame: During the intubation procedure, on average 20 minutes
Duration of mechanical ventilation
Duration of mechanical ventilation after the immediate intubation encounter
Time frame: 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
Time frame: Up to 24 hours after extubation
Number of subjects with Intraventricular hemorrhage
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New Haven, Connecticut, United States
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States
RECRUITINGWakeMed Health & Hospitals
Raleigh, North Carolina, United States
RECRUITINGPenn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGCHU Sainte-Justine
Montreal, Quebec, Canada
ACTIVE_NOT_RECRUITINGAny intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants
Time frame: Up to 7 days after birth
NICU Mortality
Death before NICU discharge
Time frame: Through study completion, on average 90 days