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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL077863 | U.S. NIH Grant/Contract | View source | |
| UH2HL125163 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Heart Association | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal Intubation | Active Comparator | The insertion of a plastic breathing tube through the mouth and into the trachea. |
|
| Laryngeal Tube (King) | Active Comparator | Insertion of a supraglottic airway (SGA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Intubation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Alive at 72 Hours After Episode. | Number of patient alive at 72 hours after episode. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Return of Spontaneous Circulation (ROSC) | Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none]. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry E Wang, MD | University of Alabama, University of Texas Health Science Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Resuscitation Center | Birmingham | Alabama | 35294 | United States | ||
| Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38967927 | Derived | 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. | |
| 31272823 | Derived | Wang 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. |
| Label | URL |
|---|---|
| Resuscitation Outcomes Consortium (ROC) Public Homepage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3,004 enrolled, 3 lost to follow-up, 1 withdrew from study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Alive at 72 Hours After Episode. | Number of patient alive at 72 hours after episode. | Posted | Count of Participants | Participants | 72 hours |
|
72 hours of hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple (>=3) attempts to insert the assigned airway. | Injury, poisoning and procedural complications | Non-systematic Assessment | Multiple attempts (>=3) to insert the assigned airway device. Based upon EMS personnel report. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry E. Wang, MD, MS | Unviersity of Texas Health Science Center at Houston | 713-500-7878 | henry.e.wang@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2016 | Feb 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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|
| Laryngeal Tube (King) | Device | 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 | Number of patients alive at time 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 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.
| From enrollment through end of hospital course. |
| Portland |
| Oregon |
| 92739 |
| United States |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente | Dallas | Texas | 75390 | United States |
| University of Washington (Data Coordinating Center) | Seattle | Washington | 98115 | United States |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 30167699 | Derived | Wang 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | The gender was "unknown" for 1 female patient in LT and 1 male patient in LT. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
|
| Secondary | Return of Spontaneous Circulation (ROSC) | Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none]. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Secondary | Number of Patients Alive at Hospital Discharge | Number of patients alive at time hospital discharge. | Outcome for 1 patient in LT group not known. | Posted | Count of Participants | Participants | From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days. |
|
|
|
| Secondary | 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.
| Neurologic status not known for 4 patients in the ETI group and 5 patients in LT group. | Posted | Count of Participants | Participants | From enrollment through end of hospital course. |
|
|
|
| 1,265 |
| 1,495 |
| 0 |
| 1,495 |
| 582 |
| 1,495 |
| EG001 | 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. | 1,230 | 1,505 | 0 | 1,505 | 173 | 1,505 |
|
| Unsuccessful insertion of assigned airway. | Injury, poisoning and procedural complications | Non-systematic Assessment | Unsuccessful efforts to insert the assigned airway device. Based upon EMS personnel reports. |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumothorax detected on first chest x-ray. Based upon radiology reports. |
|
| Rib Fracture | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Rib fractures detected on first chest x-ray. Based upon Radiology reports. |
|
| Pneumonia or Aspiration Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumonia or aspiration pneumonitis reported during first 72 hours of hospitalization. Based upon radiology reports. |
|
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