What side effects are associated with this type of intervention?

Common side effects of endotracheal intubation treatments include sore throat, hoarseness, and potential injury to the vocal cords or trachea. The use of sedative-analgesic medications can lead to respiratory depression, hypotension, and prolonged sedation. Specific types of endotracheal tubes, such as polyurethane-cuffed tubes, may reduce the risk of ventilator-associated pneumonia but can still cause complications like cuff-related tracheal injury. Personalized planning and protocols aim to minimize these risks by optimizing the choice of equipment and medications based on individual patient needs.

What prior FDA approvals exist?

The FDA has approved various drugs and protocols aimed at improving the safety and outcomes of endotracheal intubation. These include the use of sedatives and anesthetics such as midazolam and diazepam, which help reduce anxiety and discomfort during the procedure. Additionally, lidocaine is commonly used for topical anesthesia to numb the airway and reduce the risk of complications. While specific personalized planning tools like the PINS Bundle are still under study, the focus on individualized care and protocol optimization is consistent with broader trends in enhancing procedural safety and patient outcomes.

What other types of research exist?

Promising novel alternatives to the Personalized INtubation Safety (PINS) Bundle for endotracheal intubation patients in 2024 include the use of 3D-printed personalized airway models for precise stent customization and airway management, advanced simulation-based training programs for healthcare providers to improve intubation skills, and enhanced real-time monitoring systems that utilize artificial intelligence to predict and prevent complications during intubation.

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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

Summary

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tracheal intubation associated event (TIAE)

Secondary study objectives

Duration of mechanical ventilation

Magnitude of oxygen desaturation

NICU Mortality

+4 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for endotracheal intubation focus on personalized planning and standardized protocols to enhance safety and efficacy. Personalized planning involves tailoring the intubation approach to the individual patient's anatomy and clinical condition, which helps in anticipating and mitigating potential complications. Standardized protocols, such as the PINS Bundle, include steps like pre-procedural checklists, proper sedation and analgesia, and the use of advanced airway management tools. These measures ensure that the intubation is performed smoothly, reducing the risk of adverse events such as hypoxia, trauma, or unplanned extubation. This comprehensive approach is crucial for improving patient outcomes and minimizing complications during and after the intubation process.

AARC Clinical Practice Guideline: Management of Adult Patients with Tracheostomy in the Acute Care Setting.Phased Quality Improvement Interventions in Reducing Unplanned Extubation in the Neonatal ICU.Cardiorespiratory arrest in children (out of hospital).

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Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

721 Previous Clinical Trials

8,601,327 Total Patients Enrolled

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

2,014 Previous Clinical Trials

2,693,834 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

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