NCT02419573

Pragmatic Airway Resuscitation Trial

Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,004 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.

Detailed description

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies. The null hypothesis is that 72-hour survival is similar between primary Laryngeal Tube (LT) SGA and primary ETI airway management strategies. Evaluated secondary outcomes will include return of spontaneous circulation, survival to hospital discharge, neurologically intact survival at hospital discharge, airway management performance, and clinical adverse events.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	Endotracheal Intubation	In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT.
DEVICE	Laryngeal Tube (King)	In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-04-17
• Last updated: 2019-01-14
• Results posted: 2018-12-12

Locations

6 sites across 1 country: United States