Optimizing Tracheal Intubation Outcomes and Neonatal Safety
This study is about making a breathing tube insertion safer for very young babies in the intensive care unit. Often, babies in the NICU need a breathing tube, but sometimes there can be problems like difficulty placing the tube or changes in their oxygen levels. Researchers have created a new plan called the 'Personalized Intubation Safety (PINS) Bundle'. This bundle is like a checklist tailored specifically for each baby, helping doctors and nurses plan how to best insert the breathing tube. It looks at the baby's individual risks, the best medications to use, the right equipment, and who should perform the procedure. The study wants to see if using this PINS Bundle reduces problems during breathing tube insertion and improves important outcomes for babies, like how long they need the tube or their overall health.
At a glance
What is this study about?
This study is focused on helping very young babies, often called newborns or infants, who need a breathing tube in the intensive care unit (NICU). Sometimes, placing this breathing tube can be tricky and lead to problems, such as needing multiple attempts, or the baby's oxygen levels dropping during the procedure. The goal of this research is to make this procedure as safe as possible for these vulnerable babies.
To do this, doctors and nurses have developed a new plan called the 'Personalized Intubation Safety (PINS) Bundle'. Think of it as a detailed, step-by-step guide that is custom-made for each baby before the breathing tube is inserted. This personalized approach considers several important things: what specific risks the baby might have, whether a breathing tube is absolutely necessary at that moment, what medicines might help, using specialized equipment like a video camera to guide the tube, and making sure the most experienced person is doing the procedure.
The researchers want to find out if using this PINS Bundle really does reduce problems when placing a breathing tube. They also want to see if it helps babies in other ways, such as reducing the time they need the breathing tube, improving their overall health in the NICU, and preventing certain complications. By studying this new approach across several hospitals, they hope to improve care for all babies who need this vital procedure.
Key takeaways
- The study aims to make breathing tube insertion safer for babies in intensive care.
- A new planning tool, the PINS Bundle, is being tested to personalize the procedure.
- It could reduce problems during breathing tube placement.
- The study also looks at how it affects babies' overall health outcomes.
- Participation involves receiving care from a hospital using the PINS Bundle approach.
- You can always ask questions or choose not to participate.
Who may be eligible?
This study is looking for infants who are being treated in the neonatal intensive care unit (NICU) and need to have a breathing tube placed.
There are a few reasons why an infant might not be able to join the study. For example, if a baby already has a breathing tube and just needs it replaced with a new one, they wouldn't be included. This study is specifically looking at the very first time a breathing tube is inserted.
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.
- Is your baby an infant in the NICU?
- Does your baby need a breathing tube placed for the first time?
- Is your baby NOT having an existing breathing tube replaced?
- Is your baby being cared for at one of the participating hospitals?
What does participation involve?
This study is looking at the routine care provided in the NICU, so if your baby is eligible and admitted to one of the participating hospitals, the PINS Bundle approach might be used during their breathing tube procedure. You wouldn't need to attend extra visits or have additional assessments beyond what's already part of their standard medical care. There are no new medications being tested or specific follow-up appointments added just for this study; it's about evaluating an improved way of managing a procedure that might already be necessary for your baby. The total duration for your baby's involvement would be during and after the intubation procedure as their progress is tracked as part of their regular care. Essentially, it's about seeing if a different planning method for a common procedure makes a positive difference.
Potential risks and benefits
Locations (8)
- University of Arkansas Medical SciencesVerified postcodeLittle Rock, United States· Recruiting
- University of Colorado - DenverVerified postcodeDenver, United States· Recruiting
- Yale-New Haven HospitalVerified postcodeNew Haven, United States· Recruiting
- Dartmouth-Hitchcock ClinicVerified postcodeLebanon, United States· Recruiting
- WakeMed Health & HospitalsVerified postcodeRaleigh, United States· Recruiting
- Penn State Milton S. Hershey Medical CenterVerified postcodeHershey, United States· Recruiting
- University of WashingtonVerified postcodeSeattle, United States· Recruiting
- CHU Sainte-JustineVerified postcodeMontreal, Canada· Active not recruiting
Common questions
What is a 'breathing tube'?
A breathing tube is a small, soft tube placed into a baby's windpipe to help them breathe, often with the help of a machine.
What is the NICU?
NICU stands for Neonatal Intensive Care Unit. It's a special part of a hospital for newborn babies who need extra medical care.
What is the PINS Bundle?
The PINS Bundle is a personalized plan or checklist used by doctors and nurses to make placing a breathing tube safer for each baby.
Will my baby get extra tests?
No, your baby won't get any extra tests just for this study. It's about how the breathing tube procedure is planned and managed within their usual care.
Can I say no to my baby being in the study?
Yes, completely. Your decision will not affect your baby's care in any way.
How to find out more
Elizabeth Foglia, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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