Optimizing Tracheal Intubation Outcomes and Neonatal Safety (OPTION SAFE)

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.

Study Overview

• Status: Recruiting
• Conditions: Infant; Intubation Complication
• Intervention / Treatment: Other: Personalized Intubation Safety (PINS) Bundle

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 Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Foglia, MD; Phone Number: 215-590-1000; Email: foglia@chop.edu
• Study Contact Backup: Name: Hayley Buffman, MPH; Phone Number: 215-590-1000; Email: buffmanh@chop.edu

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, QC H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Principal Investigator: Ahmed Moussa, MD
      • Contact: Marie-Hélène La France; Phone Number: 514-345-4730; Email: ethique@recherche-ste-justine.qc.ca
      • Sub-Investigator: Michael-Andrew Assaad, MD
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas Medical Sciences
      • Contact: Shuk-Mei Ho, MD; Phone Number: 501-686-5391; Email: shukmeiho@uams.edu
      • Principal Investigator: Jennifer Rumpel, MD
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • University of Colorado - Denver
      • Contact: Deborah Barnard; Phone Number: 303-724-7628; Email: Deborah.barnard@ucdenver.edu
      • Principal Investigator: Rebecca Shay, MD, MAS
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale-New Haven Hospital
      • Contact: Monika Lau, MEd; Phone Number: 203-737-4434; Email: Monika.lau@yale.edu
      • Principal Investigator: Lindsay Johnston, MD, MEd
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Clinic
      • Contact: Kelly Stevens; Phone Number: 207-415-7180; Email: Kelly.j.stevens@hitchcock.org
      • Principal Investigator: Tyler Hartman, MD
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed Health & Hospitals
      • Contact: Catherine Kilday; Phone Number: 919-350-7335; Email: ckilday@wakemed.org
      • Principal Investigator: Stephen DeMeo, DO
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S. Hershey Medical Center
      • Principal Investigator: Kristen Glass, MD
      • Contact: Rafael Santos, MS, CIP; Phone Number: 814-865-4295; Email: Rms7210@psu.edu
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Johanna Salmonson; Phone Number: 206-543-4464; Email: salmoj@uw.edu
      • Principal Investigator: Ivana Brajkovic, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-Intervention Phase; NICU Patients who are intubated without the PINS Bundle.
Active Comparator: Post-intervention Phase; NICU Patients who are intubated after unit implementation of the PINS Bundle	Other: Personalized 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; Other Names: PINS Bundle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal intubation associated event (TIAE)	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	During the intubation procedure, on average 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe TIAE	Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions	During the intubation procedure, on average 20 minutes
Magnitude of oxygen desaturation	Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure	During the intubation procedure, on average 20 minutes
Number of subjects with multiple intubation attempts (>2 attempts)	More than 2 intubation attempts	During the intubation procedure, on average 20 minutes
Duration of mechanical ventilation	Duration of mechanical ventilation after the immediate intubation encounter	Through study completion, on average 90 days
Number of subjects requiring reintubation within 24 hours of extubation	Need for reintubation within 24 hours of extubation from the course of ventilation immediately following the intubation encounter	Up to 24 hours after extubation
Number of subjects with Intraventricular hemorrhage	Any intraventricular hemorrhage and grade on head ultrasound, assessed for at risk preterm infants	Up to 7 days after birth
NICU Mortality	Death before NICU discharge	Through study completion, on average 90 days

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Elizabeth Foglia, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Infant; Intubation; NICU
• Other Study ID Numbers: 22-019975; R01HD106996 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI will share unique research resources developed through this NIH-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with NIH policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
• IPD Sharing Time Frame: Data will be available after study completion
• IPD Sharing Access Criteria: The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No