Health TrialsbyHealthPanel

Cardiac Arrest Bundle of cARE Trial

ConditionsCardiopulmonary ResuscitationCardiac ArrestOut of Hospital Cardiac Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorUniversity Hospital Southampton NHS Foundation Trust

About this trial

An out-of-hospital cardiac arrest is a sudden event where the heart stops beating and a person becomes unresponsive. During this event, vital organs in the body receive no blood flow, causing them to shut down. Without intervention to restart the heart, a person effectively dies. In the UK, around 60,000 people experience cardiac arrests each year, with most occurring at home. Despite prompt emergency service response, survival rates are typically low.

There is technology available that has the potential to improve survival rates for out-of-hospital cardiac arrests. The intervention involves three devices used together: head-up position CPR (Elegard), active compression-decompression mechanical CPR (Lucas-3), and the Impedance Threshold device (Resqpod-16). When combined, these devices can enhance blood flow during resuscitation, potentially leading to improved initial resuscitation rates and higher rates of survival with normal brain function after a cardiac arrest.

A pilot study is planned to test the feasibility of using these devices. The results will inform the design of a larger study to determine if this technology can indeed improve survival rates in out-of-hospital cardiac arrests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>18 year of age) who have suffered a cardiac arrest

Body habitus is compatible with the bundle devices.

Witnessed event

Time of collapse was known with reasonable certainty to have been to be within 20 minutes.

Disqualifiers

Visibly pregnant women

Prisoners

Traumatic cardiac arrest

Drowning

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuroprotective 'bundle of care'

    Procedure/Surgery

    This includes the 3 devices: * Head up cardiopulmonary resuscitation (HUP-CPR) * Active compression decompression CPR * Impedance threshold device (ITD)

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Control (usual care)No intervention 0 interventions
Group B: Intervention 'bundle of care'Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The feasibility of initiating the 'bundle of care' (ability to recruit to the intervention, ability to place the 3 devices in the intervention group and use them as per the protocol.

The feasibility of initiating the 'bundle of care' (ability to recruit to the intervention) and to adequately perform the randomisation and crossover of each arm within each participating service, evidenced by the number of eligible patients and the number recruited.

Time frame
Through study completion an average of up to 1 year
2

Feasibility of delivering a single education package on how to use the 'bundle of care'.

The feasibility of delivering an education package to teach the procedure for the bundle of care intervention and the success of said education package, evidenced by the number of staff trained and the incidence of non-compliance. The package will contain classroom teaching and video resources.

Time frame
30 days

Secondary outcomes

1

First recorded cardiac rhythm of the participants in the trial

To record the initial cardiac arrest rhythm, asystole, pulseless electrical activity, ventricular fibrillation or ventricular tachycardia.

Time frame
30 Minutes
2

Signs of life during CPR to include a pulse, an attempt to breathe or to move

Signs of life during CPR- Presence of agonal respirations and other signs of life (pupillary response, movement during CPR)

Time frame
30 minutes
3

Maximum end tidal carbon dioxide (CO2) during CPR before ROSC.

Time frame
30 minutes
4

Return of spontaneous circulation (ROSC).

To mark the time of ROSC is it is achieved.

Time frame
60-120 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Southampton NHS Foundation Trust

Lead sponsor

University of Southampton

Collaborator

South Central Ambulance service

Collaborator

Hampshire and Isle of Wight air Ambulance

Collaborator

Source ClinicalTrials.gov
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