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Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

This study is all about making advanced breathing tube procedures, like putting a tube into a child's windpipe (tracheal intubation), as safe and efficient as possible for children in intensive care units (ICU) and emergency departments (ED) in the UK. These procedures can be very serious and carry risks. We're looking at how different hospitals currently perform these procedures for children, including babies and older children. By comparing our practices with those of other hospitals in a large network, we can identify areas where improvements can be made. The main goal is to use this information to develop and put into practice new ways of working that will help improve safety and quality for every child needing these vital treatments.

At a glance

Status
Recruiting
Sponsor
Children's Hospital of Philadelphia
Enrolment target
150,000
Start
01 Mar 2010
Estimated completion
01 Jan 2030

What is this study about?

When children are very unwell in hospital, sometimes they need help breathing. This might involve a special tube being placed in their windpipe to help deliver oxygen, a procedure known as tracheal intubation. While very important and often life-saving, these procedures can be complex and sometimes carry risks. This study is designed to understand how these advanced breathing procedures are currently carried out for children in various parts of the hospital, including general intensive care units, heart intensive care units, neonatal (newborn) intensive care units, emergency departments, and even delivery rooms.

The main reason for doing this study is to make these procedures even safer and better for children. We're gathering information on current practices across many hospitals and comparing them to see what works well and where we can improve. Think of it like a team of hospitals looking at their playbooks to find the best strategies. By collecting this information, we hope to spot any common challenges or areas where things could be smoother and safer.

Ultimately, the goal is to use all this learning to develop and introduce new ways of working that will directly improve the care children receive. This isn't about testing new medicines; it's about improving how we do things to ensure the best possible outcomes when children need advanced help with their breathing. By continuously checking how these changes are working, we can be confident that we're making a real difference to the safety and quality of care.

Key takeaways

  • Aims to make advanced breathing procedures safer for children.
  • Focuses on improving existing hospital practices, not new treatments.
  • Looks at care in ICUs, EDs, and delivery rooms for children of all ages.
  • Collects and compares data from many hospitals to find best approaches.
  • No direct involvement or changes to care for individual patients in the study.
  • Ultimately seeks to improve future care and safety for all children.

Who may be eligible?

This study is looking at care given to children of all ages, from newborns to teenagers, who undergo advanced breathing procedures in certain hospital areas. These procedures include placing a breathing tube into the windpipe, using a laryngeal mask (another type of breathing device), or performing an emergency tracheostomy (creating an opening in the neck to the windpipe) or cricothyrotomy (a similar emergency procedure).

If a child has a breathing tube removed but then needs another one put back in very soon after, this would also be included in the study as a new event. We're basically looking at any first-time event where an advanced breathing device is used outside of surgery.

However, procedures that happen within an operating theatre (surgery room) are not part of this study. The focus is specifically on advanced breathing procedures done in intensive care units (like children's, heart, and newborn ICUs), emergency departments, and delivery rooms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is the advanced breathing procedure for a child (any age, including newborns)?
  2. Did the procedure happen in an intensive care unit (PICU, CICU, NICU), emergency department, or delivery room?
  3. Was it a breathing tube placement, laryngeal mask, or emergency airway procedure?
  4. Was the procedure done outside of a main operating theatre (surgery room)?
Answer every question to see your result.

What does participation involve?

This study is not about patients directly taking part in an intervention or receiving a new treatment. Instead, we are observing and collecting information from medical records and hospital practices about what happens during advanced breathing procedures for children. There are no extra hospital visits, assessments, or medications for patients because of this study. Our healthcare teams will simply be looking at how these procedures are currently performed and documenting the details. Patients and their families will not be asked to do anything differently or attend any extra appointments related to this study. The study looks at existing care to find ways to make it better for future patients.

Potential risks and benefits

This study aims to improve the safety and quality of breathing tube procedures for children, which could lead to better outcomes for future patients. There are no direct benefits or risks to individual patients or their families participating in this study since it involves reviewing medical practices rather than active treatment. Patient privacy will be protected. Data collected will be anonymised or de-identified where possible to protect personal information. As patients are not directly involved in any intervention, there is no right to withdraw from a specific treatment; however, if you have concerns about the use of your child’s de-identified data for quality improvement, you can discuss this with your care team.

Locations (87)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Children's of Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Recruiting
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Arkansas Children's Hospital
    Verified postcode
    Little Rock, United States· Recruiting
  • Children's Hospital of Central California
    Verified postcode
    Madera, United States· Suspended
  • University of Colorado Hospital
    Verified postcode
    Aurora, United States· Recruiting
  • Yale New Haven Children's Hospital
    Verified postcode
    New Haven, United States· Recruiting
  • Yale-New Haven Children's Hospital
    Verified postcode
    New Haven, United States· Recruiting
  • Nemours Children's Health, Delaware
    Verified postcode
    Wilmington, United States· Recruiting
  • Miami Children's Hospital
    Verified postcode
    Miami, United States· Suspended
  • Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • Children's Hospital of Atlanta - Scottish Rite
    Verified postcode
    Atlanta, United States· Suspended
  • Children's Hospital of Georgia
    Verified postcode
    Augusta, United States· Recruiting

Common questions

What does 'tracheal intubation' mean?

It's when a flexible tube is gently placed into a person's windpipe to help them breathe, usually when they need a machine (ventilator) to assist them.

Is this study trialling a new medicine?

No, this study is not about new medicines. It's about improving the way important breathing procedures are currently carried out in hospitals.

Will my child receive different care because of this study?

No, your child will receive the standard and best possible care. This study is observing current practices to improve care for future patients.

Who is involved in this study?

This study involves medical professionals observing and collecting information about advanced breathing procedures for children in various hospital settings across a network of hospitals.

Will my child's personal information be kept private?

Yes, patient privacy is very important. All collected data will be handled carefully to protect personal information, often by removing any identifying details.

How to find out more

Hayley Buffman, MPH

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Improving Safety and Quality of Tracheal Intubation Practice…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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