Exception From Informed Consent (EFIC) studies

As a Learning Health System, Denver Health creates, conducts and applies research to influence and improve the care we give to our patients. Our researchers and clinical care teams collaborate daily in the search for new diagnostic and technology-driven care that improves outcomes.

Patient consent is a fundamental tenet of medical research. Yet, consent requires the patient to be fully aware of the risks and benefits. In life-threatening emergencies, patients are often unconscious, confused or in serious distress, which limits their ability to provide consent. Consequently, identifying the best care for life-threatening conditions requires a different type of consent, which occurs through a process called “Exception from Informed Consent” (EFIC).

In an EFIC study, researchers spend months consulting with their patient community to explain the risks and benefits of the study, and, ultimately, to obtain consent for it. Once the patient community for a study has been consulted, doctors can then decide to include eligible patients in the study when patients cannot consent for themselves in the moment. Once family arrives or the patient has recovered from their illness, researchers discuss the study with them to get their consent to continue in the study. EFIC studies adhere to a process that is overseen by both the U.S. Food and Drug Administration (FDA) and an independent ethics committee called an institutional review board.

In 2024, Denver Health is conducting several EFIC studies. Please email our Office of Research with any general questions about these studies and feel free to contact the Primary Investigators (PIs) listed below.

Randomized trial of sedative choice for intubation (RSI) EFIC study

The Emergency Department at Denver Health is participating in a national study to evaluate if one of two commonly used sedative medications during emergency intubation improves outcomes for severely ill adult patients. Intubation is a high-risk medical procedure that is done to put a severely ill patient on a breathing machine. One in four of these patients, or 25%, experience serious problems with blood pressure or oxygen levels during this procedure.

Some of the risks of this procedure are related to the sedative medications given to patients to make them sleepy. The two most common sedatives used for intubation are etomidate and ketamine. Both have been used for decades and are approved by the U.S. Food and Drug Administration (FDA). However, it is not known if one drug is better for patients overall, or among patients with specific medical problems.

Denver Health’s participation in this study seeks to help answer these important questions. During this study, if a seriously ill adult patient needs to be put on a breathing machine in the Denver Health Emergency Department, the emergency physician will decide if the patient is eligible for this study. Patients will only be included if the physician determines that both sedative drugs, etomidate and ketamine, are equally effective for that patient. In this case, the choice between the two drugs will be made randomly by the study. For more information on this study, please refer to the trial’s main site or contact Stacy Trent, MD in Denver Health’s emergency department.

Pedi-PART Study for Pediatric Emergencies

When a child suffers a life-threatening illness or accident, Emergency Medical Services is often the first on the scene and the first to preform 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 three 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-numbered 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. 

For more information on this study, please refer to the trial’s main site or contact Lara Rappaport in Denver Health’s Pediatric Emergency Department and Urgent Care.

 
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