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NCT Number: NCT05838690

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

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.

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Key information

Conditions

Infant Intubation Complication

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Endotracheal tube exchanges, as this represents a distinct procedure.

Treatment and study plan

Personalized Intubation Safety (PINS) Bundle

Other

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

Other names: PINS Bundle

Primary outcomes

  1. Tracheal intubation associated event (TIAE)

    Time frame: 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 outcomes

  1. Severe TIAE

    Time frame: During the intubation procedure, on average 20 minutes

    Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions

  2. Magnitude of oxygen desaturation

    Time frame: 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

  3. Number of subjects with multiple intubation attempts (>2 attempts)

    Time frame: During the intubation procedure, on average 20 minutes

    More than 2 intubation attempts

  4. Duration of mechanical ventilation

    Time frame: Through study completion, on average 90 days

    Duration of mechanical ventilation after the immediate intubation encounter

  5. Number of subjects requiring reintubation within 24 hours of extubation

    Time frame: Up to 24 hours after extubation

    Need for reintubation within 24 hours of extubation from the course of ventilation immediately following the intubation encounter

  6. Number of subjects with Intraventricular hemorrhage

    Time frame: Up to 7 days after birth

    Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants

  7. NICU Mortality

    Time frame: Through study completion, on average 90 days

    Death before NICU discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Foglia, MD

CONTACT

[email protected]

215-590-1000

Hayley Buffman, MPH

CONTACT

[email protected]

215-590-1000

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: OPTION SAFE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 1, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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