RecruitingNot ApplicableNCT05838690

Optimizing Tracheal Intubation Outcomes and Neonatal Safety


Sponsor

Children's Hospital of Philadelphia

Enrollment

3,000 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This observational study examines tracheal intubation outcomes in premature and sick newborns admitted to the neonatal intensive care unit (NICU). Tracheal intubation — inserting a breathing tube into a newborn's airway — is one of the highest-risk procedures performed in the NICU, frequently associated with oxygen desaturation, bradycardia (slow heart rate), and, in worst cases, cardiac arrest. The study systematically tracks clinical data around each intubation to identify factors associated with adverse events and areas for quality improvement. All infants undergoing tracheal intubation in the NICU are eligible. The only exclusion is endotracheal tube exchanges, which represent a different procedure with distinct risks and techniques. Despite being performed thousands of times daily in NICUs worldwide, tracheal intubation in newborns remains poorly standardized, and practices vary enormously between institutions. Adverse events during intubation are alarmingly common — some studies report serious events in over 20% of procedures. By carefully documenting the circumstances, techniques, and outcomes of each intubation attempt, this study will generate the evidence base needed to develop standardized protocols, inform training curricula, and ultimately make one of neonatology's most critical procedures safer for the most vulnerable patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPersonalized 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(8)

University of Arkansas Medical Sciences

Little Rock, Arkansas, United States

University of Colorado - Denver

Denver, Colorado, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, United States

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

CHU Sainte-Justine

Montreal, Quebec, Canada

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NCT05838690


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