Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Not Applicable

Recruiting

• Conditions: Intubation Complication; Infant
• Interventions: Other: Personalized Intubation Safety (PINS) Bundle

• Registration Number: NCT05838690
• Lead Sponsor: Children's Hospital of Philadelphia

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.

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 Timeline

• Study First Submitted: 2023-03-14
• Study Start: 2023-04-01
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-04-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Post-intervention Phase	Personalized Intubation Safety (PINS) Bundle	NICU Patients who are intubated after unit implementation of the PINS Bundle

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Severe TIAE	During the intubation procedure, on average 20 minutes	Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions
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
Number of subjects with multiple intubation attempts (>2 attempts)	During the intubation procedure, on average 20 minutes	More than 2 intubation attempts
NICU Mortality	Through study completion, on average 90 days	Death before NICU discharge

Trial Locations

Locations (8)

University of Arkansas Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Dartmouth-Hitchcock Clinic; 🇺🇸 Lebanon, New Hampshire, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Colorado - Denver; 🇺🇸 Denver, Colorado, United States

WakeMed Health & Hospitals; 🇺🇸 Raleigh, North Carolina, United States

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada