Optimizing Tracheal Intubation Outcomes and Neonatal Safety

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05838690
Status
Recruiting
Apply to this trial

Conditions

  • Infant
  • Intubation Complication

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Tracheal intubation associated event (TIAE) [ Time Frame: During the intubation procedure, on average 20 minutes ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Arkansas Medical SciencesLittle RockArkansas72205
Shuk-Mei Ho, MD
[email protected]
501-686-5391
Jennifer Rumpel, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado - DenverDenverColorado80204
Deborah Barnard
[email protected]
303-724-7628
Rebecca Shay, MD, MAS (PRINCIPAL_INVESTIGATOR)
Yale-New Haven HospitalNew HavenConnecticut06510
Monika Lau, MEd
[email protected]
203-737-4434
Lindsay Johnston, MD, MEd (PRINCIPAL_INVESTIGATOR)
Dartmouth-Hitchcock ClinicLebanonNew Hampshire03756
Kelly Stevens
[email protected]
207-415-7180
Tyler Hartman, MD (PRINCIPAL_INVESTIGATOR)
WakeMed Health & HospitalsRaleighNorth Carolina27610
Catherine Kilday
[email protected]
919-350-7335
Stephen DeMeo, DO (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Rafael Santos, MS, CIP
[email protected]
814-865-4295
Kristen Glass, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Johanna Salmonson
[email protected]
206-543-4464
Ivana Brajkovic, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
University of Arkansas Medical Sciences· Little Rock, ARUniversity of Colorado - Denver· Denver, COYale-New Haven Hospital· New Haven, CTDartmouth-Hitchcock Clinic· Lebanon, NHWakeMed Health & Hospitals· Raleigh, NCPenn State Milton S. Hershey Medical Center· Hershey, PA

Related Studies