Henry E. Wang, MD, MS
Professor and Vice Chair for Research
Department of Emergency Medicine
University of Texas Health Science Center at Houston
Paramedic Airway Management in Out-of-Hospital Cardiac Arrest – The Pragmatic Airway Resuscitation Trial (PART)
Pragmatic clinical trial; Airway resuscitation; Prehospital intubation; Endotracheal intubation; CPR; Informed consent
- The primary purpose of The Pragmatic Airway Resuscitation Trial (PART) was to determine if 72-hour survival after out-of-hospital cardiac arrest is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.
- PART was a randomized, interventional trail that included 3,004 enrolled participants and 3,000 participants in the primary analysis.
- There were no significant differences in oropharyngeal or hypopharyngeal injury, airway swelling, or pneumonia for participants that received ETI over LT.
When conducting a clinical trial, seeking informed consent from trial participants is of paramount importance. In the case of PART, written informed consent was not possible because the trial included unconscious participants in an emergency situation. Therefore for PART, Exception from Informed Consent Requirements for Emergency Research (EFIC), as mandated by the U.S. Food and Drug Administration (FDA), was applied. Learn more about EFIC.
Understanding the importance of randomized trial data and having it available for out-of-hospital emergency medicine services is an idea that will continue to be discussed in the field of pragmatic clinical research.
In a trial like PART, it is difficult to blind the interventional group. Randomization was used to gain reliable data and to compensate for the lack of blinding. In an airway trial, this is one of the accepted limitations of the trial design.
#pctGR, #clinicaltrials, #informedconsent, #resuscitation, #CPR, @Collaboratory1. @UTHealth, @henrywangmd