Cardiac Arrest Clinical Trial
— CABARETOfficial 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.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | October 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Southampton NHS Foundation trust | Southampton | England |
Lead Sponsor | Collaborator |
---|---|
University Hospital Southampton NHS Foundation Trust | Hampshire and Isle of Wight air Ambulance, South Central Ambulance service, University of Southampton |
United Kingdom,
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, — View Citation
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 S — View Citation
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 — View Citation
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-tr — View Citation
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.2011.06.0 — View Citation
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 — View Citation
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 neurologica — View Citation
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 — View Citation
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. — View Citation
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 G — View Citation
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 — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 30 Minutes | |
Secondary | 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) | 30 minutes | |
Secondary | Maximum end tidal carbon dioxide (CO2) during CPR before ROSC. | 30 minutes | ||
Secondary | Return of spontaneous circulation (ROSC). | To mark the time of ROSC is it is achieved. | 60-120 minutes | |
Secondary | 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 | 60-120 minutes | |
Secondary | To evaluate any differences between intubation and supraglottic airway use with regard to mortality. | 30 days | ||
Secondary | 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. |
30 days | |
Secondary | Survival to discharge or 30-day survival (whichever is sooner). | 30 days | ||
Secondary | 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. |
30 days | |
Secondary | 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. | 30 days |
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