An interventional study of Endotracheal Intubation and Laryngeal Tube (King) in Cardiac Arrest, sponsored by University of Alabama at Birmingham. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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 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.
966 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's enrollment of 3,004 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The insertion of a plastic breathing tube through the mouth and into the trachea.
Device: Endotracheal Intubation
Insertion of a supraglottic airway (SGA)
Device: Laryngeal Tube (King)
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.
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.
Also known as: King (LT-D), King (LTS-D), King (LT)
Number of Patients Alive at 72 Hours After Episode.
Number of patient alive at 72 hours after episode.
Time frame: 72 hours
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.
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.
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.
| Milestone | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Started | 1499 | 1505 |
| Completed | 1495 | 1505 |
| Not completed | 4 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Number of patient alive at 72 hours after episode.
| Participants | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Number of Patients Alive at 72 Hours After Episode. | 230 | 275 |
Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=\[none\].
| Participants | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Return of Spontaneous Circulation (ROSC) | 361 | 420 |
Number of patients alive at time hospital discharge.
| Participants | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Number of Patients Alive at Hospital Discharge | 121 | 163 |
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.
| Participants | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Number of Patients With Favorable Neurologic Status on Hospital Discharge | 75 | 107 |
Collected over 72 hours of hospitalization.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endotracheal Intubation | 1,265/1,495 (84.6%) | 0/1,495 (0%) | 582/1,495 (38.9%) |
| Laryngeal Tube (King) | 1,230/1,505 (81.7%) | 0/1,505 (0%) | 173/1,505 (11.5%) |
| Event | Endotracheal Intubation | Laryngeal Tube (King) |
|---|---|---|
| Unsuccessful insertion of assigned airway.Injury, poisoning and procedural complications | 573/1299 | 159/1353 |
| Pneumonia or Aspiration PneumonitisRespiratory, thoracic and mediastinal disorders | 89/398 | 120/460 |
| Multiple (>=3) attempts to insert the assigned airway.Injury, poisoning and procedural complications | 245/1299 | 61/1353 |
| Rib FractureRespiratory, thoracic and mediastinal disorders | 30/426 | 16/85 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 30/426 | 17/485 |
3,004 enrolled, 3 lost to follow-up, 1 withdrew from study.
| Age, Continuous(Years) | Endotracheal Intubation | Laryngeal Tube (King) | Total |
|---|---|---|---|
| Mean | 63 ± 16.9 | 63.2 ± 17.0 | 63.1 ± 17.0 |
| Sex: Female, Male(Participants) | Endotracheal Intubation | Laryngeal Tube (King) | Total |
|---|---|---|---|
| Female | 598 | 576 | 1174 |
| Male | 897 | 929 | 1826 |
| Race (NIH/OMB)(Participants) | Endotracheal Intubation | Laryngeal Tube (King) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 7 | 10 |
| Asian | 27 | 35 | 62 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 5 |
| Black or African American | 493 | 385 | 878 |
| White | 804 | 903 | 1707 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 163 | 170 | 333 |
| Region of Enrollment(participants) | Endotracheal Intubation | Laryngeal Tube (King) | Total |
|---|---|---|---|
| United States | 1495 | 1505 | 3000 |
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University of Alabama at Birmingham