PART: Pragmatic Airway Resuscitation Trial

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02419573
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), American Heart Association (Other), The University of Texas Health Science Center, Houston (Other)
• Enrollment: 3,004
• Locations: 6
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 500.7
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Device: Endotracheal Intubation; Device: Laryngeal Tube (King)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3004 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endotracheal Intubation The insertion of a plastic breathing tube through the mouth and into the trachea.	Device: 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.
Active Comparator: Laryngeal Tube (King) Insertion of a supraglottic airway (SGA)	Device: 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.; Other Names: King (LT-D) King (LTS-D) King (LT)

Outcome Measures

Primary Outcome Measures

1. Number of Patients Alive at 72 Hours After Episode. [72 hours]

   Number of patient alive at 72 hours after episode.

Secondary Outcome Measures

1. 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].

2. 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.

3. 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. - 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Resuscitation Center	Birmingham	Alabama	United States	35294
2	Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University	Portland	Oregon	United States	92739
3	The Pittsburgh Resuscitation Network, University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
4	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente	Dallas	Texas	United States	75390
5	University of Washington (Data Coordinating Center)	Seattle	Washington	United States	98115
6	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• University of Alabama at Birmingham
• National Heart, Lung, and Blood Institute (NHLBI)
• American Heart Association
• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Henry E Wang, MD, University of Alabama, University of Texas Health Science Center at Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 29, 2016

More Information

Additional Information:

• Resuscitation Outcomes Consortium (ROC) Public Homepage

Publications

None provided.

• Responsible Party: Henry E. Wang, MD, MS, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02419573
• Other Study ID Numbers: HL077863-PART; 5U01HL077863; UH2HL125163
• First Posted: Apr 17, 2015
• Last Update Posted: Jan 14, 2019
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Henry E. Wang, MD, MS, Principal Investigator, University of Alabama at Birmingham: cardiac arrest; cardiopulmonary resuscitation; laryngeal tube; endotracheal intubation; non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Arm/Group Title	Endotracheal Intubation	Laryngeal Tube (King)
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

Baseline Characteristics

Arm/Group Title	Endotracheal Intubation	Laryngeal Tube (King)	Total
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 Participants	1495	1505	3000
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63 (16.9)	63.2 (17.0)	63.1 (17.0)
Sex: Female, Male (Count of Participants)
Female	598 40%	576 38.3%	1174 39.1%
Male	897 60%	929 61.7%	1826 60.9%
Race (NIH/OMB) (Count of 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%	385 25.6%	878 29.3%
White	804 53.8%	903 60%	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 (participants) [Number]
United States	1495 100%	1505 100%	3000 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Alive at 72 Hours After Episode.
Description	Number of patient alive at 72 hours after episode.
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal Intubation	Laryngeal Tube (King)
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.
Measure Participants	1495	1505
Count of Participants [Participants]	230 15.4%	275 18.3%

2. Secondary Outcome

Title	Return of Spontaneous Circulation (ROSC)
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal Intubation	Laryngeal Tube (King)
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.
Measure Participants	1495	1505
Count of Participants [Participants]	361 24.1%	420 27.9%

3. Secondary Outcome

Title	Number of Patients Alive at Hospital Discharge
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.

Outcome Measure Data

Analysis Population Description

Outcome for 1 patient in LT group not known.

Arm/Group Title	Endotracheal Intubation	Laryngeal Tube (King)
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.
Measure Participants	1495	1504
Count of Participants [Participants]	121 8.1%	163 10.8%

4. Secondary Outcome

Title	Number of Patients With Favorable Neurologic Status on Hospital Discharge
Description	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.
Time Frame	From enrollment through end of hospital course.

Outcome Measure Data

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)
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.
Measure Participants	1495	1500
Count of Participants [Participants]	75 5%	107 7.1%

Adverse Events

Time Frame	72 hours of hospitalization.
Arm/Group Title	Endotracheal Intubation		Laryngeal Tube (King)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	1265/1495 (84.6%)		1230/1505 (81.7%)
Serious Adverse Events
	Endotracheal Intubation		Laryngeal Tube (King)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1495 (0%)		0/1505 (0%)
Other (Not Including Serious) Adverse Events
	Endotracheal Intubation		Laryngeal Tube (King)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	582/1495 (38.9%)		173/1505 (11.5%)
Injury, poisoning and procedural complications
Multiple (>=3) attempts to insert the assigned airway.	245/1299 (18.9%)	245	61/1353 (4.5%)	61
Unsuccessful insertion of assigned airway.	573/1299 (44.1%)	573	159/1353 (11.8%)	159
Respiratory, thoracic and mediastinal disorders
Pneumothorax	30/426 (7%)	30	17/485 (3.5%)	17
Rib Fracture	30/426 (7%)	30	16/85 (18.8%)	16
Pneumonia or Aspiration Pneumonitis	89/398 (22.4%)	89	120/460 (26.1%)	120

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.