Resuscitation Outcomes Consortium (ROC) Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest (PART)
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Accession Number
HLB02131919a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
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Study Period
December 2015 – December 2017
NHLBI Division
DCVS
Dataset(s) Last Updated
August 5, 2024
Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT02419573
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/30167699
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
None
Objectives
To determine the effect of an initial airway management strategy using laryngeal tube (LT) insertion, compared with endotracheal intubation (ETI), on survival among adults with out-of-hospital cardiac arrest (OHCA).
Background
Out-of-hospital cardiopulmonary arrest (OHCA) affects more than 350,000 adults in the United States each year, with only a low percentage of patients surviving to hospital discharge. Emergency medical services (EMS) paramedics commonly perform ETI or insertion of supraglottic airways (SGAs), such as the LT, on patients with OHCA to facilitate oxygenation and protect the lungs from aspiration of vomitus. Because SGA insertion is rapid, simple, and requires less training compared to ETI, many EMS agencies have incorporated this as the primary method of ventilation during OHCA resuscitation. However, the optimal method for OHCA advanced airway management is unknown.
Participants
Eligible patients were adults with nontraumatic OHCA treated by participating EMS agencies and requiring anticipated ventilator support or advanced airway management. A total of 3004 patients were included; 1505 assigned to initial LT and 1499 assigned to initial ETI.
Design
PART was a multicenter cluster-crossover randomized trial. The trial included 27 EMS agencies associated with US sites of the Resuscitation Outcomes Consortium (ROC). The EMS agencies were grouped into 13 randomization clusters. Each cluster selected a crossover interval of 3 or 5 months. Within each cluster, treatment assignments for consecutive intervals were computer-randomized in blocks of 2 to ensure balanced exposure to both airway groups. Crossovers between study groups could occur more than once. Treatment assignments were initial LT insertion or initial ETI. Neuromuscular blocking agents or video laryngoscopy was permitted for initial intubation efforts. The trial did not limit the number of initial LT insertion or ETI attempts. If the initial insertion efforts were unsuccessful, EMS personnel performed rescue airway management using any available airway technique. EMS personnel followed local protocols for confirmation of airway placement and management of OHCA, including field termination of resuscitation efforts. Patients receiving bag-valve mask (BVM) ventilation only were retained in their assigned treatment group per intention-to-treat principles. The trial did not prescribe clinical care at the receiving hospitals, including use of EMS airway, targeted temperature management, percutaneous coronary intervention, or the timing of withdrawal of life-sustaining therapy.
The primary outcome was 72-hour survival. Secondary outcomes included return of spontaneous circulation, survival to hospital discharge, and favorable neurological status at hospital discharge (Modified Rankin Scale score ≤3).
Conclusions
Among adults with OHCA, a strategy of initial LT insertion was associated with significantly greater 72-hour survival compared with a strategy of initial ETI. These findings suggest that LT insertion may be considered as an initial airway management strategy in patients with OHCA, but limitations of the pragmatic design, practice setting, and ETI performance characteristics suggest that further research is warranted.
Wang HE, Schmicker RH, Daya MR, et al. 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;320(8):769–778. doi:10.1001/jama.2018.7044
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Resources Available
Study Datasets OnlyStudy Documents
- Data Dictionary (PDF - 299.9 KB)
- PART Annotated Forms (PDF - 1.2 MB)
- PART Manual Of Operations (PDF - 1.5 MB)
- PART Protocol (PDF - 1.2 MB)
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