Cardiac Arrest Bundle of CARE Trial

NCT05917717 | Recruiting

• 1 other identifier: CABARET
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Cardiopulmonary Resuscitation; Cardiac Arrest; Out of Hospital Cardiac Arrest

Keywords

Cardiac Arrest; Mechanical CPR; Cardiopulmonary Resuscitation; Impedance threshold device; Active compression decompression CPR; Head up cardiopulmonary resuscitation (HUP-CPR)

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion an average of up to 1 year

• 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.

  30 days

Secondary Outcomes (10)

• First recorded cardiac rhythm of the participants in the trial

  30 Minutes

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

  30 minutes

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

  30 minutes

• Return of spontaneous circulation (ROSC).

  60-120 minutes

• Is the participant alive at hospital at the point of handover in the emergency department (i.e. sustained ROSC) or are they dead.

  60-120 minutes

Study Arms (2)

Control (usual care)

NO INTERVENTION

Usual care for a cardiac arrest patient with no deviation.

Intervention 'bundle of care'

EXPERIMENTAL

The clinical team will follow a specific sequence of actions using three devices (Elegard, Lucas-3, 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-3. 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-3 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'

Interventions

Neuroprotective 'bundle of care' PROCEDURE

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

Intervention 'bundle of care'

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Visibly pregnant women
• Prisoners
• Traumatic cardiac arrest
• Drowning
• Hanging
• DNACPR
• Have been in witnessed cardiac arrest for an estimated time of 21 minutes or more

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator
• South Central Ambulance service: collaborator
• Hampshire and Isle of Wight air Ambulance: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation trust

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Related Publications (11)

• Hawkes C, Booth S, Ji C, Brace-McDonnell SJ, Whittington A, Mapstone J, Cooke MW, Deakin CD, Gale CP, Fothergill R, Nolan JP, Rees N, Soar J, Siriwardena AN, Brown TP, Perkins GD; OHCAO collaborators. Epidemiology and outcomes from out-of-hospital cardiac arrests in England. Resuscitation. 2017 Jan;110:133-140. doi: 10.1016/j.resuscitation.2016.10.030. Epub 2016 Nov 17.

  PMID: 27865775 BACKGROUND

• Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.

  PMID: 20828914 BACKGROUND

• Perkins GD, Cooke MW. Variability in cardiac arrest survival: the NHS Ambulance Service Quality Indicators. Emerg Med J. 2012 Jan;29(1):3-5. doi: 10.1136/emermed-2011-200758. Epub 2011 Nov 1. No abstract available.

  PMID: 22045608 BACKGROUND

• Lindner TW, Soreide E, Nilsen OB, Torunn MW, Lossius HM. Good outcome in every fourth resuscitation attempt is achievable--an Utstein template report from the Stavanger region. Resuscitation. 2011 Dec;82(12):1508-13. doi: 10.1016/j.resuscitation.2011.06.016. Epub 2011 Jun 24.

  PMID: 21752524 BACKGROUND

• Moore JC, Salverda B, Rojas-Salvador C, Lick M, Debaty G, G Lurie K. Controlled sequential elevation of the head and thorax combined with active compression decompression cardiopulmonary resuscitation and an impedance threshold device improves neurological survival in a porcine model of cardiac arrest. Resuscitation. 2021 Jan;158:220-227. doi: 10.1016/j.resuscitation.2020.09.030. Epub 2020 Oct 4.

  PMID: 33027619 BACKGROUND

• Moore JC, Segal N, Lick MC, Dodd KW, Salverda BJ, Hinke MB, Robinson AE, Debaty G, Lurie KG. Head and thorax elevation during active compression decompression cardiopulmonary resuscitation with an impedance threshold device improves cerebral perfusion in a swine model of prolonged cardiac arrest. Resuscitation. 2017 Dec;121:195-200. doi: 10.1016/j.resuscitation.2017.07.033. Epub 2017 Aug 5.

  PMID: 28827197 BACKGROUND

• Kim DW, Choi JK, Won SH, Yun YJ, Jo YH, Park SM, Lee DK, Jang DH. A new variant position of head-up CPR may be associated with improvement in the measurements of cranial near-infrared spectroscopy suggestive of an increase in cerebral blood flow in non-traumatic out-of-hospital cardiac arrest patients: A prospective interventional pilot study. Resuscitation. 2022 Jun;175:159-166. doi: 10.1016/j.resuscitation.2022.03.032. Epub 2022 Apr 5.

  PMID: 35395338 BACKGROUND

• Moore JC, Pepe PE, Scheppke KA, Lick C, Duval S, Holley J, Salverda B, Jacobs M, Nystrom P, Quinn R, Adams PJ, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy PM, Coyle C, Grizzard E, Garay S, Crowe RP, Lurie KG, Debaty GP, Labarere J. Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival. Resuscitation. 2022 Oct;179:9-17. doi: 10.1016/j.resuscitation.2022.07.039. Epub 2022 Aug 4.

  PMID: 35933057 BACKGROUND

• Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.

  PMID: 26477420 BACKGROUND

• Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.

  PMID: 21879897 BACKGROUND

• Wang CH, Tsai MS, Chang WT, Huang CH, Ma MH, Chen WJ, Fang CC, Chen SC, Lee CC. Active compression-decompression resuscitation and impedance threshold device for out-of-hospital cardiac arrest: a systematic review and metaanalysis of randomized controlled trials. Crit Care Med. 2015 Apr;43(4):889-96. doi: 10.1097/CCM.0000000000000820.

  PMID: 25517475 BACKGROUND

Related Links

• Clinical trial - GRAVITY
• King County 2013 Annual Report

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• James Plumb, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James OM Plumb, PhD

CONTACT

07967319438; j.plumb@soton.ac.uk

Martina Brown

CONTACT

martina.brown@scas.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study - randomised controlled trial

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 26, 2023
• Study Start: May 24, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)