PINS Bundle for Infant Intubation Safety
(OPTION SAFE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if the PINS Bundle can make intubation safer for newborns in intensive care. The PINS Bundle involves personalized planning and using specific tools and techniques to reduce complications during intubation.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is the PINS Bundle for Infant Intubation generally safe for humans?
The PINS Bundle, also known as the Airway Safety Bundle, has been studied in various settings to improve the safety of tracheal intubations (placing a tube into the windpipe) in infants and children. Research shows that using this bundle can reduce adverse events (unwanted side effects) during intubation, suggesting it is generally safe when used properly.12345
What makes the PINS Bundle treatment unique for infant intubation safety?
The PINS Bundle is unique because it combines multiple evidence-based interventions into a structured checklist to improve the safety and quality of tracheal intubations in infants. It includes steps like risk assessment, planning, pre-procedure checks, and post-procedure reviews, which are designed to reduce adverse events during intubation.12456
What data supports the effectiveness of the PINS Bundle treatment for infant intubation safety?
Who Is on the Research Team?
Elizabeth Foglia
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
This trial is for infants who need a tracheal intubation procedure in the neonatal intensive care unit (NICU). It's not specified what conditions exclude an infant from participating, but typically those with certain health issues may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Intervention Phase
NICU patients are intubated without the PINS Bundle
Post-Intervention Phase
NICU patients are intubated after unit implementation of the PINS Bundle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Personalized Intubation Safety (PINS) Bundle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator