Cardiopulmonary ResuscitationCABARETNCT05917717
Cardiac Arrest Bundle of cARE Trial
A study testing Neuroprotective 'bundle of care' in people with Cardiopulmonary Resuscitation and Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiopulmonary Resuscitation, Cardiac Arrest, Out of Hospital Cardiac Arrest
- What is being tested?
- Neuroprotective 'bundle of care'
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martina Brown contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation trust
Southampton, England, SO16 6YD
James Plumb, PhD, 2381205308, j.plumb@soton.ac.uk
James Plumb
About this study
Official title: Cardiac Arrest Bundle of Care 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.
Read the detailed description
Out of hospital cardiac arrest (OOHCA) is the sudden cessation of effective cardiovascular circulation in the pre hospital setting. This is sadly a common occurrence within the UK with approximately 60,000 OOHCAs per year. In 30,000 of these, resuscitation is attempted by the ambulance service. Survival remains poor (2-12%) within the UK and even the best performing regions still lag someway behind exemplar global systems (Seattle 21%, Norway 25%). There are a plethora of reasons for variation in outcome, not limited to the availability of community defibrillators, the education and ability of bystanders to provide effective CPR, the response times of the emergency medical personnel, the training of emergency services personnel and their individual exposure to cardiac arrest, the availability of primary percutaneous coronary intervention, and even the availability of extracorporeal resuscitation.
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;
- 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.
- 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.
- 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.
- Being tested
- Neuroprotective 'bundle of care'
- Keywords
- Cardiac Arrest, Mechanical CPR, Cardiopulmonary Resuscitation, Impedance threshold device, Active compression decompression CPR, Head up cardiopulmonary resuscitation (HUP-CPR)
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroprotective 'bundle of care'Procedure or surgery
This includes the 3 devices:
- Head up cardiopulmonary resuscitation (HUP-CPR)
- Active compression decompression CPR
- Impedance threshold device (ITD)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Neuroprotective 'bundle of care' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (10)
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.
Measured: 30 Minutes
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)
Measured: 30 minutes
Maximum end tidal carbon dioxide (CO2) during CPR before ROSC.
Measured: 30 minutes
Return of spontaneous circulation (ROSC).
To mark the time of ROSC is it is achieved.
Measured: 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.
Is the patient alive or dead, this is a binary outcome measure
Measured: 60-120 minutes
To evaluate any differences between intubation and supraglottic airway use with regard to mortality.
Measured: 30 days
To evaluate any differences between intubation and supraglottic airway use with regard to modified Rankin score.
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.
- The patient has no significant disability; able to carry out all pre-stroke activities.
- The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.
- The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
- The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.
- The patient has severe disability; bedridden, incontinent, requires continuous care.
Measured: 30 days
Survival to discharge or 30-day survival (whichever is sooner).
Measured: 30 days
Survival with a favourable neurological outcome at hospital discharge (or 30 days) using The modified Rankin Scale (mRS)
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.
- The patient has no significant disability; able to carry out all pre-stroke activities.
- The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.
- The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
- The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.
- The patient has severe disability; bedridden, incontinent, requires continuous care.
Measured: 30 days
To complete a service user questionnaire on the delivery of the intervention.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start24 May 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study - randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, South Central Ambulance service, Hampshire and Isle of Wight air Ambulance
- Responsible party
- Sponsor
- Investigators
- James Plumb, PhD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917717
- Sponsor's protocol ID
- CABARET
- Acronym
- CABARET
- Status last verified
- Nov 2024
- First submitted
- 25 May 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will use this data to inform a definitive trial in this area
Publications
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.
PubMed 27865775Berdowski 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.
PubMed 20828914Perkins 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.
PubMed 22045608Lindner 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.
PubMed 21752524Moore 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.
PubMed 33027619Moore 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.
PubMed 28827197Kim 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.
PubMed 35395338Moore 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.
PubMed 35933057Perkins 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.
PubMed 26477420Aufderheide 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.
PubMed 21879897Wang 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.
PubMed 25517475
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrest Bundle of Care Trial
- ClinicalTrials.gov ID
- NCT05917717
- Acronym / sponsor ID
- CABARET / CABARET
- Keywords
- Cardiac Arrest, Mechanical CPR, Cardiopulmonary Resuscitation, Impedance threshold device, Active compression decompression CPR, Head up cardiopulmonary resuscitation (HUP-CPR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton, South Central Ambulance service, Hampshire and Isle of Wight air Ambulance
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Out of hospital cardiac arrest (OOHCA) is the sudden cessation of effective cardiovascular circulation in the pre hospital setting. This is sadly a common occurrence within the UK with approximately 60,000 OOHCAs per year. In 30,000 of these, resuscitation is attempted by the ambulance service. Survival remains poor (2-12%) within the UK and even the best performing regions still lag someway behind exemplar global systems (Seattle 21%, Norway 25%). There are a plethora of reasons for variation in outcome, not limited to the availability of community defibrillators, the education and ability of bystanders to provide effective CPR, the response times of the emergency medical personnel, the training of emergency services personnel and their individual exposure to cardiac arrest, the availability of primary percutaneous coronary intervention, and even the availability of extracorporeal resuscitation.
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;
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study - randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control (usual care) | No intervention | –Usual care for a cardiac arrest patient with no deviation. |
| Intervention 'bundle of care' | Experimental | Procedure: Neuroprotective '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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Visibly pregnant women
- Prisoners
- Traumatic cardiac arrest
- Drowning
- Hanging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroprotective 'bundle of care'This includes the 3 devices: * Head up cardiopulmonary resuscitation (HUP-CPR) * Active compression decompression CPR * Impedance threshold device (ITD) | Procedure or surgery | Intervention 'bundle of care' |
Primary outcome
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.
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.
10 secondary outcomes
First recorded cardiac rhythm of the participants in the trial
Time frame: 30 Minutes
Signs of life during CPR to include a pulse, an attempt to breathe or to move
Time frame: 30 minutes
Maximum end tidal carbon dioxide (CO2) during CPR before ROSC.
Time frame: 30 minutes
Return of spontaneous circulation (ROSC).
Time frame: 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.
Time frame: 60-120 minutes
To evaluate any differences between intubation and supraglottic airway use with regard to mortality.
Time frame: 30 days
To evaluate any differences between intubation and supraglottic airway use with regard to modified Rankin score.
Time frame: 30 days
Survival to discharge or 30-day survival (whichever is sooner).
Time frame: 30 days
Survival with a favourable neurological outcome at hospital discharge (or 30 days) using The modified Rankin Scale (mRS)
Time frame: 30 days
To complete a service user questionnaire on the delivery of the intervention.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publication: PubMed 27865775Hawkes 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.
- Results publication: PubMed 20828914Berdowski 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.
- Results publication: PubMed 22045608Perkins 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.
- Results publication: PubMed 21752524Lindner 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.
- Results publication: PubMed 33027619Moore 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.
- Results publication: PubMed 28827197Moore 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.
- Results publication: PubMed 35395338Kim 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.
- Results publication: PubMed 35933057Moore 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.
- Results publication: PubMed 26477420Perkins 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.
- Results publication: PubMed 21879897Aufderheide 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.
- Results publication: PubMed 25517475Wang 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.
- Clinical trial - GRAVITYLink provided by the sponsor.
- King County 2013 Annual ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will use this data to inform a definitive trial in this area
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martina Brown contact
James Plumb, PhD principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroprotective 'bundle of care' in people with Cardiopulmonary Resuscitation and Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James OM Plumb, PhD (07967319438, j.plumb@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917717, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.