Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Intubation Complication Clinical Trial

— OPTION SAFE  

Official title:

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838690
• Other study ID #: 22-019975
• Secondary ID: R01HD106996
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infant
• Intubation Complication

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