In the Spring of 2024, we will begin enrolling patients over a period of approximately five years in this multi-center trial to compare airway management devices for critically ill children ages 1 day to <18 years.

The overall goal of the study is to determine the best method for pediatric airway management. We will compare Bag valve mask (BVM), Supraglottic airways (SGA), and Endotracheal Intubation (ETI). 

The PEDI-PART trial will be conducted in 65 EMS agencies throughout the US. The study is being run by the Pediatric Emergency Care Applied Research Network (PECARN) and is supported by the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH).

Inclusion Criteria:

• At least 1-day old and < 18 years old
• Cardiopulmonary arrest, major trauma or respiratory failure
• Life-saving care initiated or continued by Pedi-PART EMS personnel
• Requiring active airway management (BVM or higher level of respiratory support)

Exclusion Criteria:

• Prisoners
• Pre-existing tracheostomy
• Do-not-resuscitate/do-not-intubate status
• Visibly Pregnant

Study Background

The objective of the Pedi-PART trial is to determine if bag-valve-mask ventilation (BVM), supraglottic airway insertion (SGA) or endotracheal intubation (ETI) is the best airway management strategy in the prehospital care of critically ill children.

Each year in the United States, EMS provides life-saving care to thousands of children suffering from critical illness such as cardiac arrest, trauma and respiratory failure. Airway management is one of the most important parts of resuscitation and enables delivery of life-saving oxygen to the lungs.

In children, the most common approaches to airway management in the prehospital setting include BVM, ETI, and SGA, including the i-gel, King-LT and laryngeal mask airway (LMA). While used every day by EMS providers, the best method for managing the pediatric airway in the prehospital setting is unknown.

Answering this question is extremely important and can save the lives of thousands of children each year.

Risks and Benefits

Cardiac arrest, trauma and respiratory failure are life-threatening conditions that necessitate immediate airway management intervention. BVM, ETI and SGA are the most widely used prehospital interventions for airway management. Information from preclinical studies support the potential for the study airway interventions to provide a direct benefit to the individual subjects.

Benefits:

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.

Risks:

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. BVM, ETI and SGA are all standard accepted methods of clinical care for critically ill children. 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.

Like all medical interventions, some side effects are possible from airway management. Risks of each airway management strategy are summarized in the table below. First pass intubation success is higher for age≥14years. Other risks are not known to vary by age or size.

There also may be risks that are unknown at this time.

If the assigned strategy of airway management should fail, EMS personnel will administer an alternate method, as is normal practice. Risks associated with the investigation are reasonable in relation to what is known about the medical conditions, and the risks and benefits of available therapies.

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 confidential information and we never use names of participants when we publish study results.

There are no psychological, social, cultural, financial or legal risks to the patient that are expected with prehospital airway management. There is potential differential risk for adverse events such as hypoxia, aspiration, pneumonitis, and pneumothorax, though equipoise exists and is the premise for establishing these as the primary and secondary outcomes that are being evaluated for this study.

This study involves no cost to the pediatric patients or their families.