Supraglottic airway device
DeviceInitial advanced airway management with a supraglottic device
Other names: LMA, King, igel
NCT Number: NCT04100564
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.
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Notify Me15 year and older
All sexes
Interventional
Not applicable
Emory University, Atlanta, Georgia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle.
If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.
Initial advanced airway management with a supraglottic device
Other names: LMA, King, igel
Initial advanced airway management with standard care method
Time frame: From injury through 24 hours
Time frame: From hospital admission through death or hospital discharge up to 30 days
Time frame: At time of placement of device through confirmation of device placement
Time frame: Admission through 30 days or discharge
Time frame: Admission through 30 days or discharge
Time frame: From initial airway management through first 24 hours of hospital admission
Time frame: At the time of placement of device through time of arrival to trauma bay
Time frame: At the time of placement of device through time of arrival to trauma bay
Time frame: At the time of placement of device through time of arrival to trauma bay
Jason Sperry
Other
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Acronym: PACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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