Clinical trial NCT05838690: Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Official title: Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant
Intubation Complication
Keywords: Infant
Intubation
NICU
Safety
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-01
Enrollment: 3000
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Tracheal intubation associated event (TIAE)
timeFrame: During the intubation procedure, on average 20 minutes
Secondary outcomes:
measure: Severe TIAE
timeFrame: During the intubation procedure, on average 20 minutes
measure: Magnitude of oxygen desaturation
timeFrame: During the intubation procedure, on average 20 minutes
measure: Number of subjects with multiple intubation attempts (>2 attempts)
timeFrame: During the intubation procedure, on average 20 minutes
measure: Duration of mechanical ventilation
timeFrame: Through study completion, on average 90 days
measure: Number of subjects requiring reintubation within 24 hours of extubation
timeFrame: Up to 24 hours after extubation
measure: Number of subjects with Intraventricular hemorrhage
timeFrame: Up to 7 days after birth
measure: NICU Mortality
timeFrame: Through study completion, on average 90 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences
state: Arkansas
city: Denver
country: United States
facility: University of Colorado - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Clinic
state: New Hampshire
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth Foglia, MD
role: PRINCIPAL_INVESTIGATOR
References: