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NCT05838690NARecruiting

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Children's Hospital of Philadelphia

Start Date

4/1/2023

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: No minimum to 1 years

Inclusion Criteria: Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU) Exclusion Criteria: Endotracheal tube exchanges, as this represents a distinct procedure.

Interventions

OTHER

Personalized Intubation Safety (PINS) Bundle

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Conditions

InfantIntubation Complication

Locations

University of Arkansas Medical Sciences

Little Rock, Arkansas 72205

United States

University of Colorado - Denver

Denver, Colorado 80204

United States

Yale-New Haven Hospital

New Haven, Connecticut 06510

United States

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire 03756

United States

WakeMed Health & Hospitals

Raleigh, North Carolina 27610

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

University of Washington

Seattle, Washington 98195

United States

CHU Sainte-Justine

Montreal, Quebec QC H3T 1C5

Canada