Optimizing Tracheal Intubation Outcomes and Neonatal Safety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Intubation Safety (PINS) Bundle.
- Who it may be relevant to
- Registry conditions: Infant, Intubation Complication. Basic parameters: up to 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Personalized 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
Primary outcome measures
- Tracheal intubation associated event (TIAE) [Time frame: During the intubation procedure, on average 20 minutes]
Secondary outcome measures (7)
- Severe TIAE [Time frame: During the intubation procedure, on average 20 minutes]
- Magnitude of oxygen desaturation [Time frame: During the intubation procedure, on average 20 minutes]
- Number of subjects with multiple intubation attempts (>2 attempts) [Time frame: During the intubation procedure, on average 20 minutes]
- Duration of mechanical ventilation [Time frame: Through study completion, on average 90 days]
- Number of subjects requiring reintubation within 24 hours of extubation [Time frame: Up to 24 hours after extubation]
- Number of subjects with Intraventricular hemorrhage [Time frame: Up to 7 days after birth]
- NICU Mortality [Time frame: Through study completion, on average 90 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 7 centers
- University of Arkansas Medical Sciences — Little Rock
- University of Colorado - Denver — Denver
- Yale-New Haven Hospital — New Haven
- Dartmouth-Hitchcock Clinic — Lebanon
- WakeMed Health & Hospitals — Raleigh
- Penn State Milton S. Hershey Medical Center — Hershey
- University of Washington — Seattle
Canada · 1 center
- CHU Sainte-Justine — Montreal
Identifiers
NCT: NCT05838690 · 22-019975 · R01HD106996