Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQueen Mary University of London

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • ER-REBOA catheter

    Device

    To achieve rapid aortic occlusion

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Aortic balloon occulsionOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 1 hour of initiation
2

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

Time frame
Within 1 hour of initiation

Secondary outcomes

1

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.

Time frame
Within 1 hour of initiation
2

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.

Time frame
Within 1 hour of initiation
3

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.

Time frame
Within 1 hour of initiation

Other outcomes

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