What is the purpose of the Pedi-PART Study?
The Pedi-PART study will determine which of the three airway management methods are best when caring for children who are critically ill and need emergency care because they have stopped breathing.
Who will be included in the study?
We will enroll children who are at least 1 day old to less than 18 years old who experience a life-threatening medical emergency requiring airway management while being treated by Emergency Medical Services (EMS) agencies who are participating in the study.
Where will the study take place?
EMS agencies from 10 different cities across the US will participate in the trial. These EMS agencies are associated with the Pediatric Emergency Care Applied Research Network (PECARN).
What treatments do patients with breathing emergencies currently receive?
The standard treatment of children who are having a breathing emergency generally involves one of three methods: bag valve mask ventilation (BVM), endotracheal intubation (ETI), or supraglottic airway (SGA). Importantly, every person included in this research will receive one of these standard care methods.
How will the airway management strategy be assigned?
EMS providers will be assigned to use a different strategy each day. For example, if it is an odd-numbered day, EMS personnel may perform SGA, while on even-numbered days, EMS personnel may perform bag valve mask ventilation.
What happens after the airway management is completed?
There are no other study procedures once the airway management has been completed. We will record some information about the 911 call and the records from EMS personnel and record whether patients live or die. There are no additional hospital or clinic visits.
Where will Pedi-PART be conducted?
EMS agencies from 10 different cities across the US will participate in the trial. These EMS agencies are associated with the Pediatric Emergency Care Applied Research Network (PECARN). The cities that will participate are:
How many patients will be included in Pedi-PART?
We are planning to include approximately 3,000 patients.
How long will it take to complete the study?
We estimate that it will take 5 years to complete the study.
How will patients be entered into the Pedi-PART study?
Patients in this study will have suffered a serious illness or injury causing difficulty breathing, therefore requiring immediate life-saving interventions. These types of emergencies occur unexpectedly, and it is not possible for people to sign up to take part ahead of time. Most patients will be unconscious (unable to speak or hear) and too sick to consent to immediate treatment or participation in the study. Patients will therefore be entered into the study prior to consent.
How can research be done without a person’s permission?
Research is normally only conducted with the expresed permission of the patient, but it is often not possible to obtain patient permission in life-threatening emergencies. However, research still has to be done because it may yield new information that can save many additional lives. The Pedi-PART trial will be therefore conducted under federal regulations that allow for an Exception From Informed Consent (EFIC).
What is Exception From Informed Consent?
In 1996, the Food and Drug Administration (FDA) developed specific regulations to permit emergency research without prospective consent. These regulations recognize that there are situations where patients or family members cannot give informed consent but research is needed to improve care. This type of research is strictly limited to special circumstances and has additional safeguards.
Link to Exception from informed consent requirements for emergency research
If a family member is present when EMS personnel arrive, will they be asked for permission?
If there is an opportunity to give study information or obtain consent before treatment, we will make every effort to do so. In order to give permission to participate in a study, it is important that the person giving permission understands what is being said to them, and can make a well-informed decision. Family members are usually very upset during a medical emergency and may not be able to concentrate or comprehend what is being said during the emergency. A serious illness or injury is an emergency during which the patient could potentially die if treatment is not begun immediately so there may not be time to ask parents or other family members for permission prior to implementing an airway management strategy. Patients with breathing emergencies may be unconscious or too sick to discuss their treatment, and any time taken to discuss their treatment with family deprives the patient of immediately starting life-saving measures.
Will the patient and/or family member be told about the study?
Yes, we will inform patients, and their relatives, as soon as possible. Most of the time, the airway management strategy will have been given by the time we are able to reach relatives, or patients themselves are able to take in such information. If a patient, or legally authorized representative, decides that they do not wish to continue to be part of the study, then no further data will be collected.
Can a person opt out of this research?
Yes, but only if the desire to opt out of research is expressed to EMS personnel prior to administering the assigned airway management strategy.
