Pragmatic Airway Resuscitation Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Endotracheal Intubation
* Device: Laryngeal Tube (King)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital cardiac arrest (OHCA) Adult (age ≥18 years or per local interpretation) Non-traumatic etiology Initiation of ventilatory support (e.g., bag-valve-mask device, non-rebreather mas, etc.) Exclusion Criteria: Known pregnant women Known prisoners Major facial trauma (visible major deformity, copious oral bleeding, etc) Major bleeding or exsanguination (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury) Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT, or other advanced airway management Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., inserted by healthcare facility personnel) Patients with a pre-existing tracheostomy Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.) Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH) Patients with pre-existing written do-not-attempt-resuscitation (DNAR) orders Inter-facility transports Patients with a do not enroll bracelet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endotracheal Intubation<br>The insertion of a plastic breathing tube through the mouth and into the trachea. | Device: Endotracheal Intubation<br>* 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.<br>|
| Active Comparator: Laryngeal Tube (King)<br>Insertion of a supraglottic airway (SGA) | Device: Laryngeal Tube (King)<br>* 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.<br>* Other names: King (LT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Alive at 72 Hours After Episode. | Number of patient alive at 72 hours after episode. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of Spontaneous Circulation (ROSC) | Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none]. | Patients will be followed from the time of the CA until death or ROSC whichever occurs first. The time frame for this secondary outcome may vary from minutes to hours, but is not expected to last longer than 12 hours. | 
| Number of Patients Alive at Hospital Discharge | Number of patients alive at time hospital discharge. | From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days. | 
| Number of Patients With Favorable Neurologic Status on Hospital Discharge | Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) <=3. MRS values for neurologic outcome include: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | From enrollment through end of hospital course. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)