Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2024-05-24
2025-08-30
Brief Summary
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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.
Detailed Description
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Despite poor outcomes from OOHCA for decades, there exists promising data from animal and cadaver studies that new technological devices could improve the currently poor blood flow generated by chest compressions during CPR, particularly cerebral blood flow. The current standard of care for patients with an OOHCA includes manual CPR delivered at a rate of 100-120 compressions per minute with a depth of 5 cm (maximum 6 cm). In turn, periodic inflation of the lungs using positive pressure ventilation to maintain oxygenation is mandated during CPR. Animal data have shown that blood flow to the heart and brain using this method is approximately 15-30% of normal. Conventional CPR is therefore unphysiological by definition, with intracerebral pressures being too high in the compression phase and intrathoracic pressure being too high in the release phase for adequate blood flow to the brain and heart respectively. Mechanisms and tools to improve this have been available for some time but using them synergistically to achieve improved cerebral and coronary blood flow is a relatively recent advance.
It is now possible to mimic a more physiologically normal situation by combining 3 pieces of technology. These may lead to better organ perfusion during CPR and therefore better rates of survival. The 3 devices in question do this in different complementary ways, in turn;
1. Head up position- gradated elevation of the head after CPR has been initiated, improves cerebral blood flow during CPR. This has been studied predominantly in porcine models. HUP-CPR enhances venous return, and reduces intracranial pressure during the decompression phase of CPR. This results in improved cerebral perfusion pressure and improves cerebral blood flow.
2. Active compression/decompression CPR uses a device with a suction cup placed on the thorax that via active decompression generates a negative intrathoracic pressure on each upward stroke, meaning that venous return to the heart improves during each cycle of CPR, allowing more blood to then be pumped to the brain on the next compressive cycle.
3. Combined with an impedance threshold device which works by limiting air entry into the lungs during chest recoil between chest compressions thereby enhancing the lower intrathoracic pressure achieved by active decompression, as described above.
The first retrospective study examining the combination of active compression decompression CPR with an ITD and HUP-CPR in humans was published in 2022, concluding that rapid initiation of bundle of care-CPR was associated with a higher likelihood of survival to hospital discharge after OHCA when compared with conventional CPR. 9. The first prospective human study using this triple bundle approach is currently ongoing in France.
The 3 devices described above are all CE marked meaning that this trial is not a trial of an experimental device and therefore does not need to be reported to the MHRA for their regulatory approvals.
Justification for undertaking the trial
Survival from OOHCA in the UK remains extremely poor (2-12%). The fact that this has not changed over many decades is of concern. Additionally, the global health disparity that exists in survival from OOCHA between different healthcare systems is stark.
The published animal data has created a plausible biological signal that improvements with cerebral blood flow are indeed possible using a bundle approach to neuroprotective CPR. The practicalities of performing this in human subjects in cardiac arrest is already being done in certain emergency medical systems globally. One study has published retrospective data with a signal to suggest that improved outcomes are possible using this approach. As far as the investigators are aware, no randomised control trial is currently being undertaken to test this hypothesis.
The proposed treatment bundle holds the potential to change this, the investigators are of the opinion that this should be tested scientifically within the remit of a clinical trial and this is the first necessary stage of that process. The individual components have shown promise in animal studies but this has not been borne out in the human trials that have followed. The synergistic and complementary effect of the 3 devices that make up the bundle of care in this study have the potential to change outcomes.
In parts of the USA (Seattle and Phoenix Fire departments) this bundle of care has been brought in due to the marked improvements in survival that have been seen. The investigators are of the opinion that an adequately powered randomised trial is essential to confirm these possible benefits.
Research statement
Out-of-hospital cardiac arrest (OOHCA) is a common event with poor long-term survival rates, often resulting in poor neurological outcomes. While there are several interventions that may improve survival and neurological outcomes, single interventions alone have not consistently demonstrated significant improvements in outcomes. The combination of head up cardiopulmonary resuscitation (CPR), active compression decompression CPR, and the use of an impedance threshold device has not yet been tested in a pragmatic randomised controlled trial. Therefore, the objective of this study is to assess the feasibility of conducting a randomized trial comparing usual care with a "bundle of care" approach incorporating the above interventions to improve patient outcomes after OOHCA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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).
Study Groups
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Control (usual care)
Usual care for a cardiac arrest patient with no deviation.
No interventions assigned to this group
Intervention 'bundle of care'
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.
Neuroprotective 'bundle of care'
This includes the 3 devices:
* Head up cardiopulmonary resuscitation (HUP-CPR)
* Active compression decompression CPR
* Impedance threshold device (ITD)
Interventions
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Neuroprotective 'bundle of care'
This includes the 3 devices:
* Head up cardiopulmonary resuscitation (HUP-CPR)
* Active compression decompression CPR
* Impedance threshold device (ITD)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
120 Years
ALL
No
Sponsors
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University of Southampton
OTHER
South Central Ambulance service
UNKNOWN
Hampshire and Isle of Wight air Ambulance
UNKNOWN
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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James Plumb, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Southampton NHS Foundation Trust
Locations
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University Hospital Southampton NHS Foundation trust
Southampton, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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James Plumb
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Clinical trial - GRAVITY
Other Identifiers
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CABARET
Identifier Type: -
Identifier Source: org_study_id