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Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation

Recruitingn/aAges 18 Years - anyAllUniversità Vita-Salute San Raffaele
NCT06538155 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Out-of-hospital cardiac arrest (OHCA) affects 275,000 people in Europe every year. In Italy alone, 50,000 people experience OHCA annually, with only 9% surviving. Half of the survivors suffer severe brain damage. Immediate CPR and defibrillation by bystanders before the ambulance arrives can save lives, but often, CPR starts only when the ambulance gets there. Additionally, half of all OHCAs occur when the person is alone, causing delays in recognizing the emergency, calling for help, and starting lifesaving actions. Effective chest compressions and defibrillation are crucial but are often not done correctly or are not customized for each patient. Current guidelines recommend the same approach for everyone, which doesn't consider individual needs. To tackle these issues, we plan to develop artificial intelligence (AI) algorithms, smartphone apps, and new devices. Our main goal is to cre

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📋 Eligibility rules (as published)
AIM 1: PREDICTION AND RECOGNITION OF CARDIAC ARREST AIM 1.1: PREDICT A MAJOR CARDIOVASCULAR EVENT Inclusion criteria: * Age 18-70 years; * Being a healthy volunteer (i.e., an individual with no history of cardiovascular events willing to contribute to the project) or a patient (survivors and non-survivors) who experienced major cardiovascular events (i.e., myocardial infarction or cardiac arrest); * Users of a smartwatch or smartphone that continuously and automatically collect health data; * Informed consent. Exclusion criteria: * Impossibility to access/export data; * User did not wear the wearable device for periods longer than 24 hours; * User did not wear the wearable device in the 4 weeks preceding the event. AIM 1.2 CARDIAC ARREST DETECTION FROM VIDEOS No patient involved. AIM 2: TECHNOLOGIES TO INCREASE CPR AND DEFIBRILLATION USE BEFORE AMBULANCE ARRIVAL No patient involved. AIM 3: PATIENT-TAILORED RESUSCITATION AIM 3.1: CLINICAL STUDY IN PATIENTS WHO RECEIVED CPR Inclusion criteria: * Adults (≥ 18 years); * Patients suffering a non-traumatic cardiac arrest treated with chest compressions (both survivors and non-survivors); * Received a TEE, chest x-ray, or chest CT scan as the standard clinical assessment following cardiac arrest; * Informed consent. Exclusion criteria: \- Patients with severe thorax/mediastinal deformity. AIM 3.2 CLINICAL STUDY IN PATIENTS WHO RECEIVED A CHEST CT SCAN Inclusion criteria: * Adults (≥ 18 years); * Received a chest CT scan for any reasons; * Informed consent. Exclusion criteria: \- Patients with severe thorax/mediastinal deformity. AIM 3.3 MACHINE LEARNING (ML) ALGORITHM No patient involved.
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What it tests

  • Wearable device
  • Cardiopulmonary resuscitation
  • CT scan, TEE exam, or chest X ray
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Where

3 sites
IRCCS Ospedale San Raffaele
Milan, Italy
AOU Policlinico Federico II
Naples, Italy
Azienda Ospedaliera Universitaria Vanvitelli
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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