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Cardiac Arrest Bundle of cARE Trial (CABARET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05917717
Recruitment Status : Not yet recruiting
First Posted : June 26, 2023
Last Update Posted : January 23, 2024
Sponsor:
Collaborators:
University of Southampton
South Central Ambulance service
Hampshire and Isle of Wight air Ambulance
Thames Valley Air Ambulance
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

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 AD), 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.


Condition or disease Intervention/treatment Phase
Cardiopulmonary Resuscitation Cardiac Arrest Out of Hospital Cardiac Arrest Procedure: Neuroprotective 'bundle of care' Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Pilot study - Cluster randomised cross over study
Masking: Single (Outcomes Assessor)
Masking Description:

The study team will not be blinded to which patients receive which arm of the trial and will be aware of what each service is delivering in each phase of the study. The research team carrying out the flow up will be blinded to the arm of the trial that the participant was in when they are collecting outcome and follow up data.

It is impossible to blind the care providers.

Participants will be blinded to which arm of the trial they were in (should they regain capacity).

Primary Purpose: Treatment
Official Title: Cardiac Arrest Bundle of Care Trial
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control (usual care)
Usual care for a cardiac arrest patient with no deviation aside from application of a cerebral saturation monitor (Near-Infrared Spectroscopy NIRS) (when available).
Experimental: Intervention 'bundle of care'
The clinical team will follow a specific sequence of actions using three devices (Elegard, Lucas AD, and ITD-16), in addition to standard CPR. Firstly, they will place the ITD onto the i-gel) or ETT, followed by the Elegard device and the LUCAS AD. The team will also place a cerebral saturation monitor on (Near-Infrared Spectroscopy (NIRS)) (if they have access to one). After 2 minutes of CPR via the LUCAS AD with the ResQPOD-16 (ITD), the Elegard device will be turned on and activated to gradually elevate the head approximately 22cm from the ground to the back of the occiput. If necessary, the clinical team may choose to intubate the trachea at this point. Resuscitation will continue for at least 30 minutes or until ROSC is achieved. If ROSC is achieved, standard post ROSC guidelines will be followed.
Procedure: Neuroprotective 'bundle of care'

This includes the 3 devices:

  • Head up cardiopulmonary resuscitation (HUP-CPR)
  • Active compression decompression CPR
  • Impedance threshold device (ITD)




Primary Outcome Measures :
  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. [ Time Frame: Through study completion an average of up to 1 year ]
    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.

  2. Feasibility of delivering a single education package on how to use the 'bundle of care'. [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. First recorded cardiac rhythm of the participants in the trial [ Time Frame: 30 Minutes ]
    To record the initial cardiac arrest rhythm, asystole, pulseless electrical activity, ventricular fibrillation or ventricular tachycardia.

  2. Signs of life during CPR to include a pulse, an attempt to breathe or to move [ Time Frame: 30 minutes ]
    Signs of life during CPR- Presence of agonal respirations and other signs of life (pupillary response, movement during CPR)

  3. Maximum end tidal carbon dioxide (CO2) during CPR before ROSC. [ Time Frame: 30 minutes ]
  4. Return of spontaneous circulation (ROSC). [ Time Frame: 60-120 minutes ]
    To mark the time of ROSC is it is achieved.

  5. Is the participant alive at hospital at the point of handover in the emergency department (i.e. sustained ROSC) or are they dead. [ Time Frame: 60-120 minutes ]
    Is the patient alive or dead, this is a binary outcome measure

  6. To evaluate any differences between intubation and supraglottic airway use with regard to mortality. [ Time Frame: 30 days ]
  7. To evaluate any differences between intubation and supraglottic airway use with regard to modified Rankin score. [ Time Frame: 30 days ]

    The Modified Rankin score is a score from 0-5 with a higher score indicating a worse neurological outcome after cardiac arrest. The values are as follows.

    0 The patient has no residual symptoms.

    1. The patient has no significant disability; able to carry out all pre-stroke activities.
    2. The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.
    3. The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
    4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.
    5. The patient has severe disability; bedridden, incontinent, requires continuous care.

  8. Survival to discharge or 30-day survival (whichever is sooner). [ Time Frame: 30 days ]
  9. Survival with a favourable neurological outcome at hospital discharge (or 30 days) using The modified Rankin Scale (mRS) [ Time Frame: 30 days ]

    The Modified Rankin score is a score from 0-5 with a higher score indicating a worse neurological outcome after cardiac arrest. The values are as follows.

    0 The patient has no residual symptoms.

    1. The patient has no significant disability; able to carry out all pre-stroke activities.
    2. The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.
    3. The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
    4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.
    5. The patient has severe disability; bedridden, incontinent, requires continuous care.

  10. To complete a service user questionnaire on the delivery of the intervention. [ Time Frame: 30 days ]
    To evaluate the opinions of the paramedics and doctors recruiting to the trial regarding the use of the equipment in the intervention group and any barriers to recruitment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (>18 year of age) who have suffered a cardiac arrest
  2. Body habitus is compatible with the bundle devices.
  3. Witnessed event
  4. Time of collapse was known with reasonable certainty to have been to be within 20 minutes.

Exclusion Criteria:

  1. Visibly pregnant women
  2. Prisoners
  3. Traumatic cardiac arrest
  4. Drowning
  5. Hanging
  6. DNACPR
  7. Have been in witnessed cardiac arrest for an estimated time of 21 minutes or more

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05917717


Contacts
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Contact: James OM Plumb, PhD 07967319438 j.plumb@soton.ac.uk
Contact: Martina Brown martina.brown@scas.nhs.uk

Locations
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United Kingdom
University Hospital Southampton NHS Foundation trust
Southampton, England, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
University of Southampton
South Central Ambulance service
Hampshire and Isle of Wight air Ambulance
Thames Valley Air Ambulance
Investigators
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Principal Investigator: James Plumb, PhD University Hospital Southampton NHS Foundation Trust
Additional Information:
Publications of Results:

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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05917717    
Other Study ID Numbers: CABARET
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will use this data to inform a definitive trial in this area

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Cardiac Arrest
Mechanical CPR
Cardiopulmonary Resuscitation
Impedance threshold device
Active compression decompression CPR
Head up cardiopulmonary resuscitation (HUP-CPR)
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases