Dataset Information

Resuscitative endovascular balloon occlusion of the aorta in out-of-hospital cardiac arrest - A Delphi consensus study for uniform data collection.

ABSTRACT:

Background

Evolving research on resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment for out-of-hospital cardiac arrest mandates uniform recording and reporting of data. A consensus on which variables need to be collected may enable comparing and merging data from different studies. We aimed to establish a standard set of variables to be collected and reported in future REBOA studies in out-of-hospital cardiac arrest.

Methods

A four-round stepwise Delphi consensus process first asked experts to propose without restraint variables for future REBOA research in out-of-hospital cardiac arrest. The experts then reviewed the variables on a 5-point Likert scale and ≥75% agreement was defined as consensus. First authors of published papers on REBOA in out-of-hospital cardiac arrest over the last five years were invited to join the expert panel.

Results

The data were collected between May 2022 and December 2022. A total of 28 experts out of 34 primarily invited completed the Delphi process, which developed a set of 31 variables that might be considered as a supplement to the Utstein style reporting of research in out-of-hospital cardiac arrest.

Conclusions

This Delphi consensus process suggested 31 variables that enable future uniform reporting of REBOA in out-of-hospital cardiac arrest.

SUBMITTER: Haugland H

PROVIDER: S-EPMC10583171 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Resuscitative endovascular balloon occlusion of the aorta in out-of-hospital cardiac arrest - A Delphi consensus study for uniform data collection.

Haugland Helge H Gamberini Lorenzo L Hoareau Guillaume L GL Haenggi Matthias M Greif Robert R Brede Jostein Rødseth JR

Resuscitation plus 20231011

<h4>Background</h4>Evolving research on resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment for out-of-hospital cardiac arrest mandates uniform recording and reporting of data. A consensus on which variables need to be collected may enable comparing and merging data from different studies. We aimed to establish a standard set of variables to be collected and reported in future REBOA studies in out-of-hospital cardiac arrest.<h4>Methods</h4>A four-round stepw ...[more]

PMID: 37859631

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Project description:ImportanceHemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care.ObjectiveTo establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination.Design, setting, and participantsThis was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study.ExposuresZI REBOA or P-REBOA.Main outcomes and measuresThe main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge.ResultsFemoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA.Conclusions and relevanceIn this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death.Trial registrationClinicalTrials.gov Identifier: NCT04145271.

Project description:Background Few patients survive after out-of-hospital cardiac arrest and any measure that improve circulation during cardiopulmonary resuscitation is beneficial. Animal studies support that resuscitative endovascular balloon occlusion of the aorta (REBOA) during cardiopulmonary resuscitation might benefit patients suffering from out-of-hospital cardiac arrest, but human data are scarce. Methods and Results We performed an observational study at the helicopter emergency medical service in Trondheim (Norway) to assess the feasibility and safety of establishing REBOA in patients with out-of-hospital cardiac arrest. All patients received advanced cardiac life support during the procedure. End-tidal CO2 was measured before and after REBOA placement as a proxy measure of central circulation. A safety-monitoring program assessed if the procedure interfered with the quality of advanced cardiac life support. REBOA was initiated in 10 patients. The mean age was 63 years (range 50-74 years) and 7 patients were men. The REBOA procedure was successful in all cases, with 80% success rate on first cannulation attempt. Mean procedural time was 11.7 minutes (SD 3.2, range 8-16). Mean end-tidal CO2 increased by 1.75 kPa after 60 seconds compared with baseline (P<0.001). Six patients achieved return of spontaneous circulation (60%), 3 patients were admitted to hospital, and 1 patient survived past 30 days. The safety-monitoring program identified no negative influence on the advanced cardiac life support quality. Conclusions To our knowledge, this is the first study to demonstrate that REBOA is feasible during non-traumatic out-of-hospital cardiac arrest. The REBOA procedure did not interfere with the quality of the advanced cardiac life support. The significant increase in end-tidal CO2 after occlusion suggests improved organ circulation during cardiopulmonary resuscitation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03534011.

Project description:BackgroundOut-of-hospital cardiac arrest (OHCA) is a critical incident with a high mortality rate. Augmentation of the circulation during cardiopulmonary resuscitation (CPR) might be beneficial. Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) redistribute cardiac output to the organs proximal to the occlusion. Preclinical data support that patients in non-traumatic cardiac arrest might benefit from REBOA in the thoracic level during CPR. This study describes a training programme to implement the REBOA procedure to a prehospital working team, in preparation to a planned clinical study.MethodsWe developed a team-based REBOA training programme involving the physicians and paramedics working on the National Air Ambulance helicopter base in Trondheim, Norway. The programme consists of a four-step approach to educate, train and implement the REBOA procedure in a simulated prehospital setting. An objective structured assessment of prehospital REBOA application scoring chart and a special designed simulation mannequin was made for this study.ResultsSeven physicians and 3 paramedics participated. The time needed to perform the REBOA procedure was 8.5 (6.3-12.7) min. The corresponding time from arrival at scene to balloon inflation was 12.0 (8.8-15) min. The total objective assessment scores of the candidates' competency was 41.8 (39-43.5) points out of 48. The advanced cardiovascular life support (ACLS) remained at standard quality, regardless of the simultaneous REBOA procedure.ConclusionThis four-step approach to educate, train and implement the REBOA procedure to a prehospital working team ensures adequate competence in a simulated OHCA setting. The use of a structured training programme and objective assessment of skills is recommended before utilising the procedure in a clinical setting. In a simulated setting, the procedure does not add significant time to the prehospital resuscitation time nor does the procedure interfere with the quality of the ACLS.Trial registration numberNCT03534011.

Project description:BackgroundOut-of-hospital cardiac arrest (OHCA) is a significant public health issue worldwide and is associated with low survival rates and poor neurological outcomes. The generation of optimal coronary perfusion pressure (CPP) via high-quality chest compressions is a key factor in enhancing survival rates. However, it is often challenging to provide adequate CPP in real-world cardiopulmonary resuscitation (CPR) scenarios. Based on animal studies and human trials on improving CPP in patients with nontraumatic OHCA, resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising technique in these cases. This study aims to investigate the benefits of REBOA adjunct to CPR compared with conventional CPR for the clinical management of nontraumatic OHCA.MethodsThis is a parallel-group, randomized, controlled, multinational trial that will be conducted at two urban academic tertiary hospitals in Korea and Taiwan. Patients aged 20-80 years presenting with witnessed OHCA will be enrolled in this study. Eligible participants must fulfill the inclusion criteria, and written informed consent should be collected from their legal representatives. Patients will be randomly assigned to the intervention (REBOA-CPR) or control (conventional CPR) group. The intervention group will receive REBOA and standard advanced cardiovascular life support (ACLS). Meanwhile, the control group will receive ACLS based on the 2020 American Heart Association guidelines. The primary outcome is the return of spontaneous circulation (ROSC). The secondary outcomes include sustained ROSC, survival to admission, survival to discharge, neurological outcome, and hemodynamic changes.DiscussionOur upcoming trial can provide essential evidence regarding the efficacy of REBOA, a mechanical method for enhancing CPP, in OHCA resuscitation. Our study aims to determine whether REBOA can improve treatment strategies for patients with nontraumatic OHCA based on clinical outcomes, thereby potentially providing valuable insights and guiding further advancements in this critical public health area.Trial registrationClinicalTrials.gov NCT06031623. Registered on September 9, 2023.

Dataset Information

Resuscitative endovascular balloon occlusion of the aorta in out-of-hospital cardiac arrest - A Delphi consensus study for uniform data collection.

Background

Methods

Results

Conclusions

Publications

Resuscitative endovascular balloon occlusion of the aorta in out-of-hospital cardiac arrest - A Delphi consensus study for uniform data collection.

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