OPTION SAFE: Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Pre-Intervention Phase NICU Patients who are intubated without the PINS Bundle. |
|
| Active Comparator: Post-intervention Phase NICU Patients who are intubated after unit implementation of the PINS Bundle |
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
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 2 | University of Colorado - Denver | Denver | Colorado | United States | 80204 |
| 3 | Yale-New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 4 | Dartmouth-Hitchcock Clinic | Lebanon | New Hampshire | United States | 03756 |
| 5 | WakeMed Health & Hospitals | Raleigh | North Carolina | United States | 27610 |
| 6 | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 7 | University of Washington | Seattle | Washington | United States | 98195 |
| 8 | CHU Sainte-Justine | Montréal | Quebec | Canada | QC H3T 1C5 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Elizabeth Foglia, MD, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-019975
- R01HD106996