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Pragmatic Airway Resuscitation Trial (PART)

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ClinicalTrials.gov Identifier: NCT02419573
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : December 12, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Henry E. Wang, MD, MS, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cardiac Arrest
Interventions Device: Endotracheal Intubation
Device: Laryngeal Tube (King)
Enrollment 3004
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 1499 1505
Completed 1495 1505
Not Completed 4 0
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             1             0
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 1495 1505 3000
Hide Baseline Analysis Population Description
3,004 enrolled, 3 lost to follow-up, 1 withdrew from study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1495 participants 1505 participants 3000 participants
63  (16.9) 63.2  (17.0) 63.1  (17.0)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1495 participants 1505 participants 3000 participants
Female
598
  40.0%
576
  38.3%
1174
  39.1%
Male
897
  60.0%
929
  61.7%
1826
  60.9%
[1]
Measure Description: The gender was "unknown" for 1 female patient in LT and 1 male patient in LT.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1495 participants 1505 participants 3000 participants
American Indian or Alaska Native
3
   0.2%
7
   0.5%
10
   0.3%
Asian
27
   1.8%
35
   2.3%
62
   2.1%
Native Hawaiian or Other Pacific Islander
3
   0.2%
2
   0.1%
5
   0.2%
Black or African American
493
  33.0%
385
  25.6%
878
  29.3%
White
804
  53.8%
903
  60.0%
1707
  56.9%
More than one race
2
   0.1%
3
   0.2%
5
   0.2%
Unknown or Not Reported
163
  10.9%
170
  11.3%
333
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1495 participants 1505 participants 3000 participants
1495 1505 3000
1.Primary Outcome
Title Number of Patients Alive at 72 Hours After Episode.
Hide Description Number of patient alive at 72 hours after episode.
Time Frame 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1495 1505
Measure Type: Count of Participants
Unit of Measure: Participants
230
  15.4%
275
  18.3%
2.Secondary Outcome
Title Return of Spontaneous Circulation (ROSC)
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1495 1505
Measure Type: Count of Participants
Unit of Measure: Participants
361
  24.1%
420
  27.9%
3.Secondary Outcome
Title Number of Patients Alive at Hospital Discharge
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome for 1 patient in LT group not known.
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1495 1504
Measure Type: Count of Participants
Unit of Measure: Participants
121
   8.1%
163
  10.8%
4.Secondary Outcome
Title Number of Patients With Favorable Neurologic Status on Hospital Discharge
Hide Description

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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Neurologic status not known for 4 patients in the ETI group and 5 patients in LT group.
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1495 1500
Measure Type: Count of Participants
Unit of Measure: Participants
75
   5.0%
107
   7.1%
Time Frame 72 hours of hospitalization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endotracheal Intubation Laryngeal Tube (King)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Endotracheal Intubation Laryngeal Tube (King)
Affected / at Risk (%) Affected / at Risk (%)
Total   1265/1495 (84.62%)      1230/1505 (81.73%)    
Show Serious Adverse Events Hide Serious Adverse Events
Endotracheal Intubation Laryngeal Tube (King)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1495 (0.00%)      0/1505 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Endotracheal Intubation Laryngeal Tube (King)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   582/1495 (38.93%)      173/1505 (11.50%)    
Injury, poisoning and procedural complications     
Multiple (>=3) attempts to insert the assigned airway. * [1]  245/1299 (18.86%)  245 61/1353 (4.51%)  61
Unsuccessful insertion of assigned airway. * [2]  573/1299 (44.11%)  573 159/1353 (11.75%)  159
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  [3]  30/426 (7.04%)  30 17/485 (3.51%)  17
Rib Fracture  [4]  30/426 (7.04%)  30 16/85 (18.82%)  16
Pneumonia or Aspiration Pneumonitis  [5]  89/398 (22.36%)  89 120/460 (26.09%)  120
*
Indicates events were collected by non-systematic assessment
[1]
Multiple attempts (>=3) to insert the assigned airway device. Based upon EMS personnel report.
[2]
Unsuccessful efforts to insert the assigned airway device. Based upon EMS personnel reports.
Indicates events were collected by systematic assessment
[3]
Pneumothorax detected on first chest x-ray. Based upon radiology reports.
[4]
Rib fractures detected on first chest x-ray. Based upon Radiology reports.
[5]
Pneumonia or aspiration pneumonitis reported during first 72 hours of hospitalization. Based upon radiology reports.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Henry E. Wang, MD, MS
Organization: Unviersity of Texas Health Science Center at Houston
Phone: 713-500-7878
Responsible Party: Henry E. Wang, MD, MS, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02419573     History of Changes
Other Study ID Numbers: HL077863-PART
5U01HL077863 ( U.S. NIH Grant/Contract )
UH2HL125163 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2015
First Posted: April 17, 2015
Results First Submitted: October 2, 2018
Results First Posted: December 12, 2018
Last Update Posted: January 14, 2019