Cardiac Arrest
Conditions
Keywords
cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
Brief 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.
Interventions
DEVICEEndotracheal 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.
DEVICELaryngeal 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Alive at 72 Hours After Episode. | 72 hours | Number of patient alive at 72 hours after episode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return of Spontaneous Circulation (ROSC) | 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. | Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=\[none\]. |
| Number of Patients Alive at 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 alive at time hospital discharge. |
| Number of Patients With Favorable Neurologic Status on Hospital Discharge | From enrollment through end of hospital course. | Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) \<=3. MRS values for neurologic outcome include: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endotracheal Intubation The insertion of a plastic breathing tube through the mouth and into the trachea.
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. | 1,495 |
| Laryngeal Tube (King) Insertion of a supraglottic airway (SGA)
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. | 1,505 |
| Total | 3,000 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Endotracheal Intubation | Total | Laryngeal Tube (King) |
|---|---|---|---|
| Age, Continuous | 63 Years STANDARD_DEVIATION 16.9 | 63.1 Years STANDARD_DEVIATION 17 | 63.2 Years STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 27 Participants | 62 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 493 Participants | 878 Participants | 385 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 163 Participants | 333 Participants | 170 Participants |
| Race (NIH/OMB) White | 804 Participants | 1707 Participants | 903 Participants |
| Region of Enrollment United States | 1495 participants | 3000 participants | 1505 participants |
| Sex: Female, Male Female | 598 Participants | 1174 Participants | 576 Participants |
| Sex: Female, Male Male | 897 Participants | 1826 Participants | 929 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1,265 / 1,495 | 1,230 / 1,505 |
| other Total, other adverse events | 582 / 1,495 | 173 / 1,505 |
| serious Total, serious adverse events | 0 / 1,495 | 0 / 1,505 |
Outcome results
Primary
Number of Patients Alive at 72 Hours After Episode.
Number of patient alive at 72 hours after episode.
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation | Number of Patients Alive at 72 Hours After Episode. | 230 Participants |
| Laryngeal Tube (King) | Number of Patients Alive at 72 Hours After Episode. | 275 Participants |
Secondary
Number of Patients Alive at Hospital Discharge
Number of patients alive at time hospital discharge.
Time frame: From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.
Population: Outcome for 1 patient in LT group not known.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation | Number of Patients Alive at Hospital Discharge | 121 Participants |
| Laryngeal Tube (King) | Number of Patients Alive at Hospital Discharge | 163 Participants |
Secondary
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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: From enrollment through end of hospital course.
Population: Neurologic status not known for 4 patients in the ETI group and 5 patients in LT group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation | Number of Patients With Favorable Neurologic Status on Hospital Discharge | 75 Participants |
| Laryngeal Tube (King) | Number of Patients With Favorable Neurologic Status on Hospital Discharge | 107 Participants |
Secondary
Return of Spontaneous Circulation (ROSC)
Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=\[none\].
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation | Return of Spontaneous Circulation (ROSC) | 361 Participants |
| Laryngeal Tube (King) | Return of Spontaneous Circulation (ROSC) | 420 Participants |