Emergency Services Clinical Research

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 perform life-saving medical methods to restore or maintain breathing before the child can get to the hospital.

The Pedi-PART study will determine which of the three airway management methods is best when caring for children who are critically ill and need emergency care because they have stopped breathing.

This study will compare 3 methods that are used every day by emergency medical providers to manage airways and support breathing. The three methods to be compared will be Bag-valve mask, endotracheal intubation, and a Supraglottic airway, which may also be called an SGA or could be called by a brand-name, such as i-gel.

In this study, providers will be assigned to use a different device each day. For example, if it is an odd day, the airway method assigned may be the SGA or i-gel and providers would use that method instead of bag-valve mask alone or intubation.

Risks and Benefits

Most of the risks in the Pedi-PART study are the same as the risks of standard care. If the assigned airway method doesn’t work well, providers will try another method, just like they would if there was no study. Potential benefits of the study intervention include faster airway management, which may result in fewer side effects and better results or outcomes after receiving emergency care. Since we don’t know which of the 3 methods is best, we don’t know which group will experience risks or benefit, if any.

Because treating a child who stops breathing must be done immediately, there may not be time to ask parents for permission to enroll their child. Parents will be notified after their child is enrolled and will decide if they want to continue to participate.

Learn more about the Pedi-PART study and provide your feedback by visiting our website: The Pediatric Prehospital Airway Resuscitation Trial (Columbus, Ohio) - Center for Injury Science | UAB

Contact Information

Julie C. Leonard, MD, MPH
PediPart@NationwideChildrens.org
(220) 216-0009

What is sepsis?

Sepsis is a potentially life threatening response to infection that can

• Happen to someone of any age
• Cause damage to the body’s organs
• Prevent a person from being able to function normally or independently
• Limit awareness and cause coma
• Cause death

What is PRoMPT BOLUS?

Emergency department (ED) care for suspected sepsis in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known. The purpose of this study is to find out which of two commonly used IV fluids types given in the emergency department for sepsis is the most effective.

• Normal Saline (NS)
• Balanced fluids (including lactated Ringer’s and Plasma-Lyte)

Who will be included?

• Any child who is older than 6 months and less than 18 years of age, and
• Is suspected to have sepsis by their medical team in the emergency department

Half of the study participants will be randomly selected to receive NS and the other half will be randomly selected to receive balanced fluids. All other tests and medications will be given according to normal routines in the hospital. Any fluid that a patient needs will be given as study fluid during the first 1-2 days in the hospital. Study team members will follow patients to see which fluid worked the best.

What are the benefits?

Both NS and balanced fluids are commonly used to treat sepsis and both are FDA-approved and effective in sepsis. But, because we do not know if one fluid is better for treating sepsis, we cannot know if a particular person enrolled in the study will receive a better fluid than he or she may have otherwise received.

Based on the information we get from this study, people who have sepsis in the future may benefit from what is learned during this study.

What are the risks?

Even though fluids can be life-saving, there are risks to receiving the study fluids. But the risks of the study fluids are similar to those that a patient might have if they receive fluid treatment for their sepsis outside of this study. Although all study patients will receive a fluid type that is effective, safe, and recommended for treatment of sepsis, the reason for this study is to determine which fluid may be the most effective and safest. Therefore, if there are differences in effectiveness and safety, then length of stay in hospital may be different between groups and one fluid may have higher mortality than the other.

How is enrollment different?

Whenever possible, researchers get permission before a person can be included in a study. But when a person has sepsis, it can be difficult to give consent. Also, since sepsis must be treated quickly, there is often not be enough time to locate and talk to the person’s parent or guardian about the study. So, we expect that most patients will be enrolled in the study without his/her parent or guardian’s consent. This is called “ Exception from Informed Consent” (EFIC ). Once the parent or guardian is located or the patient improves, they will be told about the study and asked to give their permission to continue in the study.

What is EFIC?

The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception from Informed Consent” (EFIC), that research studies in certain emergency situations to be conducted without consent. EFIC can only be used when:

• The person’s life is at risk, AND,
• The best treatment is not known, AND
• The study might help the person, AND
• It is not possible to get permission:
  • from the person because of his or her medical condition nor
  • from the person’s guardian because there is a very short amount of time required to treat the medical problem

Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback.

Why do this study?

The best possible outcomes in patients with sepsis likely depend on timely treatment in the ED with the most effective fluids along with antibiotics and other medicines.

This study will help us to determine which of two commonly used fluids in the treatment of children with sepsis leads to the best outcomes.

What if I don't want my child to participate?

Call us (see contact information below) to request that an Opt Out bracelet be sent to you to wear with the words "PROMPT BOLUS declined." You will need to wear this bracelet at all times during the study period, or else you could be enrolled in the emergency department. If you do not participate in the study, you will receive the standard medical treatment provided for sepsis.

Where can I learn about the study?

Learn more here. If you would like to know about a community meeting near you or to get more information about the PROMPT BOLUS study, call (614) 722-6910 or email PRoMPTBOLUS@NationwideChildrens.org.