About this trial
This study will assess the feasibility of performing pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) in patients suffering from non-traumatic out of hospital cardiac arrest (OHCA). As well as providing valuable insights into the technical feasibility of performing this procedure as part of a resuscitation attempt, the study will also document the beneficial physiological effects of REBOA in this group of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-Traumatic OHCA in patients within the East of England area AND with a East Anglian Air Ambulance (EAAA) REBOA team in attendance
Patients below or equal to 80yrs of age and above or equal to 18yrs of age, according to available information/estimate at scene
No flow <10 mins from data available (i.e. total period in OHCA with no CPR)
In cardiac arrest (with no sustained ROSC) on arrival of the EAAA REBOA team
Disqualifiers
Patients aged less than 18 or above 80 years
Known terminal illness
Multiple severe co-morbidities
Traumatic Cardiac Arrest (TCA)
Trial design
Sequential
Treatments tested in this trial
ER-REBOA catheter
DeviceTo achieve rapid aortic occlusion
Treatment groups
Trial outcomes
Primary outcomes
Device delivery
The proportion of patients where Pre-Hospital Zone 1 REBOA for OHCA is achieved, with balloon inserted to 35 - 55 cm, proximal arterial blood pressure transduced and evidence of loss of distal invasive blood pressure trace during CPR confirming aortic occlusion.
Procedural timings
Time taken to achieve REBOA for OHCA in mins * Time taken from start of the procedure (arterial catheterization) to balloon inflation in mins * Total duration of REBOA (inflation to final deflation) in mins * Time from arrival at scene to REBOA (balloon inflation) in mins * Time from 999 call to REBOA (balloon inflation) in mins
Secondary outcomes
Haemodynamic and oxygenation responses
Change in aortic diastolic pressure in mmHg * Change in central venous pressure in mmHg * Change in calculated coronary perfusion pressure (where cannulated) (CPP) mmHg These hemodynamic end-points will be presented as a consecutive case series (continuous data plots per patient) and a descriptive summary for the whole cohort of absolute values and change in values between key time intervals: Pre-occlusion, During Occlusion, Post- Occlusion.
Near Infra-Red Spectrometry
Change in brain regional oxygen saturation (rSO2) in % These cerebral oxygenation end-points will be presented as a consecutive case series (continuous data plots per patient) and a descriptive summary for the whole cohort of absolute values and change in values between key time intervals: Pre-occlusion, During Occlusion, Post- Occlusion.
End Tidal CO2
Change in ETCO2 in KPa These circulatory-surrogate end-points will be presented as a consecutive case series (continuous data plots per patient) and a descriptive summary for the whole cohort of absolute values and change in values between key time intervals: Pre-occlusion, During Occlusion, Post- Occlusion.
Sponsors and contacts
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Queen Mary University of London
Lead sponsor
East Anglian Air Ambulance
Collaborator
Rosetrees Trust
Collaborator
The Dowager Countess Eleanor Peel Trust
Collaborator
The Drummond Foundation
Collaborator