Cardiac Arrest Bundle of Care Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility of delivering a single education package on how to use the 'bundle of care'.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Visibly pregnant women
- •Traumatic cardiac arrest
- •Have been in witnessed cardiac arrest for an estimated time of 21 minutes or more
研究组 & 干预措施
Control (usual care)
Usual care for a cardiac arrest patient with no deviation.
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.
干预措施: Neuroprotective 'bundle of care' (Procedure)
结局指标
主要结局
Feasibility of delivering a single education package on how to use the 'bundle of care'.
时间窗: 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.
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.
时间窗: 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.
次要结局
- Survival to discharge or 30-day survival (whichever is sooner).(30 days)
- 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)
- Return of spontaneous circulation (ROSC).(60-120 minutes)
- To evaluate any differences between intubation and supraglottic airway use with regard to mortality.(30 days)
- To evaluate any differences between intubation and supraglottic airway use with regard to modified Rankin score.(30 days)
- Maximum end tidal carbon dioxide (CO2) during CPR before ROSC.(30 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)
- Survival with a favourable neurological outcome at hospital discharge (or 30 days) using The modified Rankin Scale (mRS)(30 days)
- To complete a service user questionnaire on the delivery of the intervention.(30 days)
