Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Infant; Intubation Complication

Treatments: Other: Personalized Intubation Safety (PINS) Bundle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05838690

22-019975

R01HD106996 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)

Exclusion criteria

Endotracheal tube exchanges, as this represents a distinct procedure.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Pre-Intervention Phase

No Intervention group

Description:

NICU Patients who are intubated without the PINS Bundle.

Post-intervention Phase

Active Comparator group

Description:

NICU Patients who are intubated after unit implementation of the PINS Bundle

Treatment:

Other: Personalized Intubation Safety (PINS) Bundle