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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05838690
Other study ID # 22-019975
Secondary ID R01HD106996
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date June 30, 2027

Study information

Verified date March 2024
Source Children's Hospital of Philadelphia
Contact Elizabeth Foglia, MD
Phone 215-590-1000
Email foglia@chop.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date June 30, 2027
Est. primary completion date April 30, 2027
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU) Exclusion Criteria: Endotracheal tube exchanges, as this represents a distinct procedure.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada CHU Sainte-Justine Montréal Quebec
United States University of Colorado - Denver Denver Colorado
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Dartmouth-Hitchcock Clinic Lebanon New Hampshire
United States University of Arkansas Medical Sciences Little Rock Arkansas
United States Yale-New Haven Hospital New Haven Connecticut
United States WakeMed Health & Hospitals Raleigh North Carolina
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Severe TIAE Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions During the intubation procedure, on average 20 minutes
Secondary 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 During the intubation procedure, on average 20 minutes
Secondary Number of subjects with multiple intubation attempts (>2 attempts) More than 2 intubation attempts During the intubation procedure, on average 20 minutes
Secondary Duration of mechanical ventilation Duration of mechanical ventilation after the immediate intubation encounter Through study completion, on average 90 days
Secondary 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
Secondary 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
Secondary NICU Mortality Death before NICU discharge Through study completion, on average 90 days
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