Cardiac ArrestPARTNCT02419573
Pragmatic Airway Resuscitation Trial
A study testing Endotracheal Intubation and Laryngeal Tube (King) in people with Cardiac Arrest, run by University of Alabama at Birmingham at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Endotracheal Intubation and Laryngeal Tube (King)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,004 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alabama Resuscitation Center
Birmingham, Alabama, 35294
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente
Dallas, Texas, 75390
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, 92739
University of Washington (Data Coordinating Center)
Seattle, Washington, 98115
About this study
Official title: Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- Endotracheal Intubation, Laryngeal Tube (King)
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal IntubationDevice
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)Device
Also called King (LT-D), King (LTS-D), King (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.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Intubation | Active comparator | The insertion of a plastic breathing tube through the mouth and into the trachea. Receives: Device: Endotracheal Intubation |
| Laryngeal Tube (King) | Active comparator | Insertion of a supraglottic airway (SGA) Receives: Device: Laryngeal Tube (King) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Alive at 72 Hours After Episode.
Number of patient alive at 72 hours after episode.
Measured: 72 hours
Secondary outcomes (3)
Return of Spontaneous Circulation (ROSC)
Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].
Measured: 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.
Measured: 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.
- - 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.
Measured: From enrollment through end of hospital course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start1 Dec 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Henry E. Wang, MD, MS, University of Alabama at Birmingham
- Investigators
- Henry E Wang, MD, Principal investigator, University of Alabama, University of Texas Health Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419573
- Sponsor's protocol ID
- HL077863-PART
- Other IDs
- 5U01HL077863, UH2HL125163
- Acronym
- PART
- Status last verified
- Dec 2018
- First submitted
- 25 Feb 2015
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nassal MMJ, Elola A, Aramendi E, Jaureguibeitia X, Powell JR, Idris A, Raya Krishnamoorthy BP, Daya MR, Aufderheide TP, Carlson JN, Stephens SW, Panchal AR, Wang HE. Temporal Trends in End-Tidal Capnography and Outcomes in Out-of-Hospital Cardiac Arrest: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419274. doi: 10.1001/jamanetworkopen.2024.19274.
PubMed 38967927Wang HE, Humbert A, Nichol G, Carlson JN, Daya MR, Radecki RP, Hansen M, Callaway CW, Pedroza C. Bayesian Analysis of the Pragmatic Airway Resuscitation Trial. Ann Emerg Med. 2019 Dec;74(6):809-817. doi: 10.1016/j.annemergmed.2019.05.009. Epub 2019 Jul 2.
PubMed 31272823Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
PubMed 30167699
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02419573
- Acronym / sponsor ID
- PART / HL077863-PART
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, laryngeal tube, endotracheal intubation, non-traumatic Out of Hospital Cardiac Arrest (OOHCA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,004 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, The University of Texas Health Science Center, Houston
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Intubation | Active comparator | Device: Endotracheal IntubationThe insertion of a plastic breathing tube through the mouth and into the trachea. |
| Laryngeal Tube (King) | Active comparator | Device: Laryngeal Tube (King)Insertion of a supraglottic airway (SGA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal IntubationIn 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. | Device | Endotracheal Intubation |
| Laryngeal Tube (King)Also: King (LT-D), King (LTS-D), King (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. | Device | Laryngeal Tube (King) |
Primary outcome
Number of Patients Alive at 72 Hours After Episode.
Time frame: 72 hours
Number of patient alive at 72 hours after episode.
3 secondary outcomes
Return of Spontaneous Circulation (ROSC)
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
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
Time frame: From enrollment through end of hospital course.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38967927Nassal MMJ, Elola A, Aramendi E, Jaureguibeitia X, Powell JR, Idris A, Raya Krishnamoorthy BP, Daya MR, Aufderheide TP, Carlson JN, Stephens SW, Panchal AR, Wang HE. Temporal Trends in End-Tidal Capnography and Outcomes in Out-of-Hospital Cardiac Arrest: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419274. doi: 10.1001/jamanetworkopen.2024.19274.
- Derived from this study: PubMed 31272823Wang HE, Humbert A, Nichol G, Carlson JN, Daya MR, Radecki RP, Hansen M, Callaway CW, Pedroza C. Bayesian Analysis of the Pragmatic Airway Resuscitation Trial. Ann Emerg Med. 2019 Dec;74(6):809-817. doi: 10.1016/j.annemergmed.2019.05.009. Epub 2019 Jul 2.
- Derived from this study: PubMed 30167699Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
- Resuscitation Outcomes Consortium (ROC) Public HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry E Wang, MD principal investigator
University of Alabama, University of Texas Health Science Center at Houston
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation and Laryngeal Tube (King) in people with Cardiac Arrest, run by University of Alabama at Birmingham at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Alive at 72 Hours After Episode. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419573, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.