Trial Outcomes & Findings for Pragmatic Airway Resuscitation Trial (NCT NCT02419573)
NCT ID: NCT02419573
Last Updated: 2019-01-14
Results Overview
Number of patient alive at 72 hours after episode.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3004 participants
Primary outcome timeframe
72 hours
Results posted on
2019-01-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1499
|
1505
|
|
Overall Study
COMPLETED
|
1495
|
1505
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pragmatic Airway Resuscitation Trial
Baseline characteristics by cohort
| Measure |
Endotracheal Intubation
n=1495 Participants
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.
|
Laryngeal Tube (King)
n=1505 Participants
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.
|
Total
n=3000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
598 Participants
n=5 Participants
|
576 Participants
n=7 Participants
|
1174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
897 Participants
n=5 Participants
|
929 Participants
n=7 Participants
|
1826 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
493 Participants
n=5 Participants
|
385 Participants
n=7 Participants
|
878 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
804 Participants
n=5 Participants
|
903 Participants
n=7 Participants
|
1707 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
163 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1495 participants
n=5 Participants
|
1505 participants
n=7 Participants
|
3000 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hoursNumber of patient alive at 72 hours after episode.
Outcome measures
| Measure |
Endotracheal Intubation
n=1495 Participants
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.
|
Laryngeal Tube (King)
n=1505 Participants
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.
|
|---|---|---|
|
Number of Patients Alive at 72 Hours After Episode.
|
230 Participants
|
275 Participants
|
SECONDARY outcome
Timeframe: 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=\[none\].
Outcome measures
| Measure |
Endotracheal Intubation
n=1495 Participants
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.
|
Laryngeal Tube (King)
n=1505 Participants
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.
|
|---|---|---|
|
Return of Spontaneous Circulation (ROSC)
|
361 Participants
|
420 Participants
|
SECONDARY outcome
Timeframe: 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.
Number of patients alive at time hospital discharge.
Outcome measures
| Measure |
Endotracheal Intubation
n=1495 Participants
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.
|
Laryngeal Tube (King)
n=1504 Participants
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.
|
|---|---|---|
|
Number of Patients Alive at Hospital Discharge
|
121 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Endotracheal Intubation
n=1495 Participants
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.
|
Laryngeal Tube (King)
n=1500 Participants
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.
|
|---|---|---|
|
Number of Patients With Favorable Neurologic Status on Hospital Discharge
|
75 Participants
|
107 Participants
|
Adverse Events
Endotracheal Intubation
Serious events: 0 serious events
Other events: 582 other events
Deaths: 1265 deaths
Laryngeal Tube (King)
Serious events: 0 serious events
Other events: 173 other events
Deaths: 1230 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Endotracheal Intubation
n=1495 participants at risk
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.
|
Laryngeal Tube (King)
n=1505 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Multiple (>=3) attempts to insert the assigned airway.
|
18.9%
245/1299 • Number of events 245 • 72 hours of hospitalization.
|
4.5%
61/1353 • Number of events 61 • 72 hours of hospitalization.
|
|
Injury, poisoning and procedural complications
Unsuccessful insertion of assigned airway.
|
44.1%
573/1299 • Number of events 573 • 72 hours of hospitalization.
|
11.8%
159/1353 • Number of events 159 • 72 hours of hospitalization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.0%
30/426 • Number of events 30 • 72 hours of hospitalization.
|
3.5%
17/485 • Number of events 17 • 72 hours of hospitalization.
|
|
Respiratory, thoracic and mediastinal disorders
Rib Fracture
|
7.0%
30/426 • Number of events 30 • 72 hours of hospitalization.
|
18.8%
16/85 • Number of events 16 • 72 hours of hospitalization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia or Aspiration Pneumonitis
|
22.4%
89/398 • Number of events 89 • 72 hours of hospitalization.
|
26.1%
120/460 • Number of events 120 • 72 hours of hospitalization.
|
Additional Information
Henry E. Wang, MD, MS
Unviersity of Texas Health Science Center at Houston
Phone: 713-500-7878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place