To watch Pedi-Part Video, Click HERE
When a child suffers a life-threatening illness or accident, Emergency Medical Services (EMS) is often the first on the scene and the first to saving medical strategies to restore or maintain breathing before the child can get to the hospital.
The Pedi-PART study is designed to determine the best strategy to restore or maintain breathing in children.
There are three methods that EMS personnel currently use to maintain/restore breathing in children:
- Bag valve mask ventilation (BVM): paramedics place a tight-fitting mask on top of the face and squeeze oxygen in through the mouth and nose and into the lungs.
- endotracheal intubation (ETI): paramedics place a plastic tube down the throat through the voice box and squeeze oxygen into the windpipe and lungs.
- 3) supraglottic airway insertion (SGA): paramedics place a special tube in the mouth and down the throat above the voice box and squeeze oxygen into the windpipe and lungs.
In this study, we will determine which method works best for child survival by comparing the 3 methods that are used every day by emergency medical providers to manage airways and support breathing.
Participating EMS agencies will be assigned to use a different method each day. This will allow researchers to compare the effectiveness of each method. If the assigned method is unsuccessful then EMS may rescue with any other airway method.
EMS agencies from 10 different cities across the US will participate in the trial. These EMS agencies are collaborating with the Pediatric Emergency Care Applied Research Network (PECARN Link).
The cities that will participate are:
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Participating Hospital(s) |
Participating EMS Agencies |
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Denver Health |
Denver Health Paramedic Division |
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Children’s Hospital Colorado |
Colorado Springs FD |
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UC Health- University of Colorado |
Aurora Fire Rescue |
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Benefits of Participating
Participants have the potential for direct benefit because some airway management techniques may be easier and faster to use or help provide oxygen to the body with fewer complications.
What we learn from this study may help children in the future who experience a life-threatening breathing emergency and may help EMS agencies develop protocols to provide better care for children.
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Study Risks
Children enrolled in this study are experiencing a life-threatening event and many will go on to experience severe outcomes, including death. We do not anticipate that participation in the Pedi-PART study will significantly increase or decrease the risk of these outcomes.
Although all of the airway management techniques in this study are commonly used to treat respiratory emergencies, we do not know if one treatment is better than another, or if one of the techniques has greater risks.
Like all medical interventions, some side effects are possible from airway management. The inability to deliver oxygen to the lungs is the biggest risk of any airway management strategy. The risk of vomiting is also common to all of the airway management techniques. Vomiting can lead to complications such as aspiration (breathing fluid into the lungs).
There also may be risks that are unknown at this time.
Accidental disclosure of protected health information is a risk common to participation in any research study that uses medical records. The study team takes extra measures to ensure protection of your child’s confidential information and we never use names of participants when we publish study results.
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Emergency Research
Research is done to improve healthcare and is regulated by oversight agencies like the U.S. Food and Drug Administration (FDA) and organizations that review and approve research called Institutional Review Boards (IRBs).
Research for emergency conditions is hard to do because there may not be enough time to talk to participants and their families about participating before treatment is needed.
The Pedi-PART study is designed to allow emergency medical providers to deliver life-saving care as quickly as possible, without interruptions. There may not be enough time to discuss the study information before the participant is enrolled in the study because providers need to focus on helping the child breathe. For this reason, participants in this study will most likely be enrolled before we can give study information to parents. Parents and children enrolled in the study will be notified as soon as possible and they will be able to decide if they want to continue to participate. For more information, visit our Exception from Informed Consent Page.
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Contact Us
If you have questions about the Pedi-PART study in your community, research staff can be contacted at (303) 724-2578 or via email at pediPART@childrenscolorado.org.
Do you have any comments you would like to tell the researchers about this study? We would value your feedback via the link below. Your feedback will remain confidential.