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Behavioural Intervention

PINS Bundle for Infant Intubation Safety (OPTION SAFE Trial)

N/A

Recruiting

Led By Elizabeth Foglia, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average 90 days

Awards & highlights

OPTION SAFE Trial Summary

This trial will test a tool to help make intubation safer in NICUs, with the goal of improving patient outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing the Personalized INtubation Safety (PINS) Bundle, which is a planning tool designed to improve the safety and outcomes of intubation procedures in newborns within NICUs.See study design

What are the potential side effects?

Since this trial involves a procedural planning tool rather than a drug or medical device, traditional side effects are not applicable. However, there could be risks associated with any changes to standard intubation practices.

OPTION SAFE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, on average 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, on average 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tracheal intubation associated event (TIAE)

Secondary outcome measures

Duration of mechanical ventilation

Magnitude of oxygen desaturation

NICU Mortality

+4 more

OPTION SAFE Trial Design

2Treatment groups

Active Control

Group I: Pre-Intervention PhaseActive Control1 Intervention

NICU Patients who are intubated without the PINS Bundle.

Group II: Post-intervention PhaseActive Control1 Intervention

NICU Patients who are intubated after unit implementation of the PINS Bundle

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,578,303 Total Patients Enrolled

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

1,963 Previous Clinical Trials

2,671,650 Total Patients Enrolled

Elizabeth Foglia, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

1 Previous Clinical Trials

21 Total Patients Enrolled

Media Library

Personalized Intubation Safety (PINS) Bundle (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05838690 — N/A

Endotracheal Intubation Research Study Groups: Pre-Intervention Phase, Post-intervention Phase

Endotracheal Intubation Clinical Trial 2023: Personalized Intubation Safety (PINS) Bundle Highlights & Side Effects. Trial Name: NCT05838690 — N/A

Personalized Intubation Safety (PINS) Bundle (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838690 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this research endeavor?

"According to the clinicaltrials.gov data, this research project is currently open for recruitment and has been since April 1st 2023. It was last modified on April 21st of that same year."

Answered by AI

Approximately how many participants are enrolled in this clinical research study?

"This medical study necessitates the enrolment of 3000 eligible participants, who may register at any one of a number of locations including University of Colorado - Denver in Denver and Yale-New Haven Hospital in New Haven."

Answered by AI

Is this trial in process at a multitude of locations within the city?

"The research is being conducted at the University of Colorado - Denver in Denver, Yale-New Haven Hospital in New Haven and Dartmouth-Hitchcock Clinic in Lebanon as well as other centres across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

2023. "Optimizing Tracheal Intubation Outcomes and Neonatal Safety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838690.