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NCT07452016
Sudden cardiac arrest is a major health problem, and most people don't survive. One big reason is that even if resuscitation is successful, people commonly have recurrent cardiac arrests (rearrest). Right now, it is not possible to accurately predict a rearrest or prevent it. The investigators have developed a machine learning device that uses the heart tracing (ECG) to predict when and why a rearrest occurs. The investigators plan to test if it will accurately and effectively help EMS providers predict rearrest and provide timely treatment to increase survival after cardiac arrest. To determine if this machine learning device will work in the real world, the investigators need to find out if there are barriers to using it, and whether EMS providers will think it is useful and will help them improve the care of patients who have a cardiac arrest. The investigators will first test the device in live simulated cardiac arrest scenarios to see if the providers can use it and if they find the device potentially valuable in taking care of patients. In a second study, the investigators will test how accurate the device is in predicting if a cardiac arrest will happen again in patients who have just been brought back to life after a cardiac arrest. EMS providers will attach the device, but it will only work in the background. EMS will take care of patients as they normally would, without using or knowing what the device says. To see if the device is accurate at predicting another cardiac arrest, the investigators will analyze the results offline, and compare what the device says to what actually happens to the patient. By comparing what the device predicts to what actually happens, the investigators can see how well it predicts another cardiac arrest and estimate how it might improve treatment of patients.
NCT07468292
Cardiac arrest (CA) with return of spontaneous circulation is associated with high mortality, exceeding 90% in out-of-hospital settings and approaching 50% in in-hospital settings. Despite management of the underlying cause of CA, patients often die from post-anoxic brain injury or from ischemia-reperfusion injury occurring after reperfusion and reoxygenation, which increases oxidative stress and leads to multi-organ failure. To date, no effective therapeutic strategy has been established in humans to limit these ischemia-reperfusion injuries. GC7 (N1-guanyl-1,7 diaminoheptane) has demonstrated a strong protective potential against ischemia reperfusion injury in rodent and porcine models, including myocardial infarction, stroke, and renal transplantation. These protective effects are attributed to the pleiotropic action of GC7 which renders cells and tissues energetically less dependent on oxygen, and reduces oxidative stress which play a major role in ischemia reperfusion injury. Degree of blood acidification and immune dysregulation may also represent parameters that GC7 could potentially influence. Although no adverse effects have been reported in these experimental models, GC7 has not yet been studied in human. Our study therefore aims to demonstrate the protective effect of GC7 on blood cells in patients after CA by evaluating oxidative stress levels, blood acidification and inflammatory profile.
NCT07438938
Out-of-hospital cardiac arrest (OHCA) is a leading cause of death worldwide. Despite constantly improving resuscitation techniques, the chances of survival remain limited. During cardiopulmonary resuscitation (CPR), a closure of the airway may occur, impeding ventilation. This phenomenon also complicates the interpretation of the end-tidal CO2 (ETCO2) in the capnogram. The extent to which airway closure occurs is quantified by the Airway Opening Index (AOI). This can be calculated from the capnogram and is seen as a measure of the quality of CPR applied as well as a possible indicator to predict the outcome of CPR. In this study, we analyse capnogram data from approximately 150 cases, collected during interventions for OHCA and logged in the Lazarus database (UZ Gent and AZORG) to answer three research questions below: 1. What is the prevalence of AOI during CPR? 2. Is there a correlation between AOI and return of spontaneous circulation (ROSC)? 3. Does the application of positive end-expiratory pressure (PEEP) affect the AOI and ROSC? A mathematical model for calculating AOI, based on a method from previous work by Bandhari et al. \[1\] will be developed. Using this model, the AOI will be calculated from the individual capnograms for all cases in the Lazarus database. In addition, a multivariable regression model will be used to analyse whether AOI can be used to predict ROSC. Corrections will be made for relevant confounders such as age, gender, witnessed arrest and rhythm pattern. Finally, it is investigated whether PEEP has a positive influence on AOI. This study aims to contribute to better insights into airway dynamics during CPR and the optimization of ventilation in OHCA.
NCT07363772
\<Study Design\> This study is a cluster-randomized, stratified, non-inferiority trial designed to evaluate the feasibility, efficacy, and educational effectiveness of HEROS 4.0, a mixed-reality (MR)-based cardiopulmonary resuscitation (CPR) training system, compared with conventional instructor-led CPR training. \<Objective \& Hypothesis\> The primary objective is to determine whether MR-based HEROS 4.0 CPR training is non-inferior to standard video- and instructor-based CPR training in improving CPR performance quality. The central hypothesis is that participants trained using HEROS 4.0 will achieve comparable CPR quality to those trained using traditional methods, while benefiting from enhanced immersion, scalability, and accessibility. \<Participants\> A total of 120 adults aged 18-50 years who have not received CPR training within the previous 12 months will be recruited. Participants will be assigned to one of two clusters and randomized in a 1:1 ratio to either the HEROS 4.0 MR training group or the conventional CPR training group. \<Intervention \& Control\> Participants will undergo CPR training according to their assigned group: Intervention group (HEROS 4.0): Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training. As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit. After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth. Control group (Conventional CPR training): Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice. \<Outcomes\> Immediately after training, all participants will undergo a standardized cardiac arrest simulation using a CPR quality-measurement manikin. This simulation will assess objective CPR performance metrics as well as subjective outcomes through questionnaires. To evaluate knowledge retention and skill durability, all assessments will be repeated 6 months after training using the same simulation scenario and outcome measures. The primary outcome is chest compression fraction measured during the standardized simulated cardiac arrest scenario. Secondary outcomes include quantitative measures of CPR quality and participant-reported outcomes based on survey.
NCT05738148
When a baby is born with a low heart rate or no heart rate, the clinical team must provide breathing support and chest compressions (what is call cardiopulmonary resuscitation or CPR). In some situations, the clinical team also need to give medications to help the heart rate increase. During CPR, the most common medication given is called epinephrine. There is another medication called vasopressin that is available that could be beneficial to newborn babies. However, no study has compared epinephrine with vasopressin in the delivery room during neonatal CPR. The current study will be the first trial comparing this two medications during neonatal CPR. The investigators will randomize our hospital to either epinephrine or vasopressin for the duration of one year. Babies will either receive CPR with epinephrine (this will be the control group) or CPR with vasopressin ( this will be the intervention group). The investigators believe that vasopressin may be more helpful to babies with a low heartrate or no heart rate at birth.
NCT07358793
This study employed a two-group non-randomized pre-post design to evaluate the effectiveness of interprofessional ISS training over one year at the National Taiwan University Hospital Yunlin Branch. The research implements the A-C-L-S teamwork model for adult non-trauma resuscitation teams, comparing the impacts of ISS versus Off-site Simulation (OSS) on team performance. Emergency department teams are assigned between two campuses: ISS at Douliu campus and OSS at Huwei campus. Each training session follows a standardized protocol: twenty-minute briefing, ten-minute high-fidelity simulation, and thirty-minute structured debriefing. The assessment utilizes the Team Emergency Assessment Measure (TEAM) scale for non-technical skills evaluation, alongside secondary outcomes including resuscitation process, CPR quality, and patient outcome indicators. External ACLS instructor-qualified experts conduct blinded evaluations of recorded scenarios to analyze team performance and training transfer. The study aims to deliver benefits across three dimensions: establishing evidence-based education models to enhance resuscitation team efficiency and patient outcomes; strengthening institutional teaching and research capacity through standardized assessment mechanisms; and developing systematic data collection processes with localized quality indicators for early error detection and improvement.
NCT06939335
The goal of this clinical trial is to learn whether using Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves outcomes for adults who experience out-of-hospital cardiac arrest, a condition where the heart suddenly stops beating. PEEP is used during ventilation, which may enhance oxygen levels by keeping the airways open throughout CPR. This study aims to determine if using PEEP during CPR helps restart the heart more effectively, improves survival rates, and enhances survival with good neurologic outcomes after a cardiac arrest compared to standard CPR without PEEP. Researchers will randomly assign participants to one of two groups: one receiving CPR with PEEP set at 5 cm of water pressure and the other receiving standard CPR without PEEP. Participants will be treated by emergency medical teams trained in advanced life support, and specialised sensors will measure airflow and airway pressure during resuscitation. Additionally, the study will evaluate potential side effects associated with PEEP, such as increased pressure within the chest or lung injuries. Findings from this trial will guide recommendations on the usage of PEEP in standard CPR practices to potentially improve patient outcomes.
NCT07351435
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.
NCT04972526
The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.
NCT07329842
High-quality chest compressions are critical for outcomes after pediatric cardiac arrest, yet rescuer ergonomics and bed height may adversely affect compression quality and fatigue. This randomized crossover simulation study will evaluate how four different bed-height settings influence pediatric CPR quality and rescuer biomechanics. Pediatric emergency medicine residents will perform 2-minute chest-compression-only CPR on a pediatric manikin placed on a hospital bed under four bed-height conditions in randomized order across separate sessions. CPR quality metrics from the manikin's feedback system, rescuer fatigue, physiologic responses, and arm angle over time will be compared to identify an ergonomically optimal bed-height approach.
NCT06835491
To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)
NCT06530433
The rise in out-of-hospital cardiac arrest (OHCA) cases in Singapore highlights the need for effective bystander cardiopulmonary resuscitation (BCPR). Despite many lay responders performing CPR, survival rates with good neurological outcomes have not significantly improved, prompting research into the quality of CPR as a critical factor. The study by Gallagher EJ et al. showed a significant survival improvement with high-quality CPR. To address this, the Unit of Pre-hospital and Emergency Research (UPEC) trained thousands of community first responders (CFRs) in simplified CPR techniques using hands-only and DA-CPR methods. A significant innovation is the CPRcard®, developed by Laerdal in Norway, which offers real-time feedback on the quality of chest compressions. However, only 36% of CFRs using the CPRcard® achieved the desired compression standards, indicating room for improvement. The study proposes enhancing CFR support with information communication technology (ICT), enabling two-way audio and one-way video communication between CFRs and dispatchers. This aims to reduce stress among responders, increase their willingness to engage with OHCA alerts, and improve CPR quality. The clinical trial in Singapore will compare the current system against the enhanced CFR support system (eCSS), focusing on the real-time relay of CPR performance data, communication ease, and implementation factors. The high-quality CFR and OHCA registries in Singapore provide a robust setting for this research, aiming to enhance CPR delivery and improve OHCA outcomes through technology and real-time support.
NCT07143357
The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.
NCT03138005
The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
NCT06567912
This study aims to establish a novel transesophageal echocardiography (TEE) simulation curriculum based on previous research results and suggestions from the American College of Emergency Physicians. To better evaluate the efficacy of the curriculum, an evaluation model utilizing artificial intelligence (AI) would be introduced. The study population is at least 60 junior physicians in the emergency department or other departments interested in TEE. After the curriculum, junior physicians could utilize TEE on cardiac arrest patients and improve diagnostic accuracy and patient outcomes.
NCT07184593
The goal of this observational study is to evaluate whether whole blood H3.1 nucleosome levels can predict 30-day mortality in adult critically ill patients admitted to the ICU with conditions such as sepsis, septic shock, cardiogenic shock, severe trauma, post-cardiac arrest, acute brain injury, or severe acute pancreatitis. The main questions it aims to answer are: Do initial whole blood H3.1 nucleosome levels predict 30-day mortality in critically ill patients? Are whole blood nucleosome measurements using a novel point-of-care device correlated with traditional plasma chemiluminescence immunoassays (ChLIA)? If there is a comparison group: Researchers will compare point-of-care whole blood nucleosome results with plasma ChLIA assays to see if the device provides reliable and feasible bedside measurements. Participants will: Provide blood samples at admission, 6h, Day 1, Day 3, and Day 7 for nucleosome analysis. Undergo point-of-care H3.1 nucleosome measurement and parallel plasma storage for ChLIA testing. (If applicable, in acute brain injury patients with external ventricular drains) provide daily cerebrospinal fluid samples until Day 5, only if otherwise discarded. Have standard ICU data (SOFA, SAPS II, etc.) collected as part of routine care.
NCT07177755
Standard predictors of outcome after cardiac arrest (CA) have substantial limitations in terms of reliability and generalizability. By providing brain structural connectivity maps, or connectomes, advanced MRI techniques, operating through high-strength magnetic field (HF; 1.5 to 3-T), have precisely revealed white and grey brain matter damages induced by CA, and have demonstrated the high sensitivity and specificity of these indicators for predicting neurological outcome after CA. However, HF MRI requires rigid safety precautions, highly trained technicians and patient transport to dedicated hospital imaging suites, hindering the implementation of these promising neuroimaging techniques in the setting of critical illness. Interestingly, a recent report demonstrates the capability of a proof-of-concept very low-field (VLF; 0.064-T) mobile MRI to obtain neuroimaging at the bedside in critically ill patients. Nevertheless, the spatial resolution of VLF-MRI seems low and there is no available evidence about the use of VLF-MRI to extract highly needed new predictors of neurological recovery based on critical brain structural connectomes. The CUBE project holds the promise of providing a radical paradigm shift in the field of neuroprognostication of anoxic coma patients. The current proposal is a "proof-of concept" study which aims to compare for the first time, HF, VLF and enhanced VLF (recon-VLF) structural connectomes from anoxic coma patients and healthy subjects across the time (3 paired HF and VLF brain scan across the first two weeks after CA). To obtain recon-VLF data, the Investigators will use an ensemble of ground-breaking methods to increase the native spatial resolution of VLF-MRI data. The whole brain imaging dataset will be used to prepare future neuroprognostication studies based on fully bedside assessment of brain structural integrity after CA.
NCT05482945
Preclinical studies suggest that argon (Ar) might diminish the neurological and myocardial damage after any hypoxic-ischemic insult. Indeed, Ar has been tested in different models of ischemic insult, at concentrations ranging from 20% up to 80%. Overall, Ar emerged as a protective agent on cells, tissues and organs, showing less cell death, reduced infarct size and faster functional recovery. More specifically, encouraging data has been reported in animal studies on cardiac arrest (CA) in which a better and faster neurological recovery was achieved when Ar was used in the post-resuscitation ventilation. More importantly, these benefits have been replicated in different studies, enrolling both small and large animals. Finally, ventilation with Ar in O2 has been demonstrated to be safe both in animals and humans. Based on this evidence, a clinical translation is advocated. Thus, the CardioPulmonary resuscitation with Argon - CPAr trial has been conceived. The trial initially started as phase I-II trial to specifically address the question about the safety of the post resuscitation Ar-treatment. The available data on the first 30 randomized patients, evaluated by the Data Safety Monitoring Board (DSMB), were considered absolutely reassuring with regard to the safety of the experimental treatment. In this perspective, the DSMB supported the continuation of the study as a phase II trial, maintaining the study protocol in all its aspects. Thus, the aim of the CPAr trial is now to evaluate efficacy in reducing post-CA neurological injury of Ar/O2 ventilation in patients resuscitated from CA.
NCT07176754
The investigators assessed the effect of TNF-α antagonism within 6 hours of return of spontaneous circulation on 30-day mortality in patients who remained comatose after cardiopulmonary resuscitation (CPR) following cardiac arrest . In addition, the investigators explored the role of this treatment in modulating the systemic inflammatory response and its potential impact on 90- and 180-day morbidity and mortality and neurological outcomes.
NCT06046339
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published. After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population. It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.