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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD106996 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Intervention Phase | No Intervention | NICU Patients who are intubated without the PINS Bundle. | |
| Post-intervention Phase | Active Comparator | NICU Patients who are intubated after unit implementation of the PINS Bundle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Intubation Safety (PINS) Bundle | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the intubation procedure, on average 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Severe TIAE | Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions | During the intubation procedure, on average 20 minutes |
| Magnitude of oxygen desaturation |
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Inclusion Criteria:
Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)
Exclusion Criteria:
Endotracheal tube exchanges, as this represents a distinct procedure.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Foglia, MD | Contact | 215-590-1000 | foglia@chop.edu | |
| Hayley Buffman, MPH | Contact | 215-590-1000 | buffmanh@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Foglia, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
The PI will share unique research resources developed through this NIH-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with NIH policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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Data will be available after study completion
The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure
| During the intubation procedure, on average 20 minutes |
| Number of subjects with multiple intubation attempts (>2 attempts) | More than 2 intubation attempts | During the intubation procedure, on average 20 minutes |
| Duration of mechanical ventilation | Duration of mechanical ventilation after the immediate intubation encounter | 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 | Up to 24 hours after extubation |
| Number of subjects with Intraventricular hemorrhage | Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants | Up to 7 days after birth |
| NICU Mortality | Death before NICU discharge | Through study completion, on average 90 days |
| University of Colorado - Denver | Recruiting | Denver | Colorado | 80204 | United States |
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| Yale-New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Dartmouth-Hitchcock Clinic | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| WakeMed Health & Hospitals | Recruiting | Raleigh | North Carolina | 27610 | United States |
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| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| CHU Sainte-Justine | Active, not recruiting | Montreal | Quebec | QC H3T 1C5 | Canada |