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RECRUITING
NCT06538155

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

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

Summary

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 create tools and technologies to improve the recognition of OHCA and provide timely and effective interventions, ultimately reducing the impact of OHCA and improving survival rates. First, we aim to create an AI algorithm that can predict major cardiovascular events like heart attacks or cardiac arrests minutes, hours, or days before they happen. We will collect data from wearable devices to train and validate this algorithm, helping us identify individuals at risk. By alerting these individuals, they can seek emergency care and receive treatment before a cardiac arrest occurs. We will also work on recognizing OHCA cases from surveillance camera footage when they happen to people who are alone. Second, to increase the rate of CPR and defibrillation before ambulances arrive, we will develop a smartphone app that geolocates and alerts nearby citizens to act as first responders. The app will guide them on how to quickly find a defibrillator and use it. Third, to find the best spots on the chest for compressions and defibrillation, we will study chest scans from CTs and echocardiograms in both elective patients and cardiac arrest victims. This will help us understand the effects of compressing different heart structures and develop a sensor to determine the optimal positions for compressions and defibrillator pads. Our multidisciplinary team of clinicians, researchers, and engineers will conduct experimental, simulation, and observational studies to develop these technologies, evaluate their potential for patents, design a plan for their use, and test their effectiveness in preventing and recognizing OHCA. We believe that by improving each step in the chain of survival-preventing cardiac events, early recognition, timely CPR and defibrillation, and high-quality advanced resuscitation-we can significantly improve treatment times and reduce the global death and disability rates caused by OHCA.

Official title: Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation: the TIME-CARE Project

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-01-27

Completion Date

2026-08-31

Last Updated

2025-08-06

Healthy Volunteers

Yes

Interventions

DEVICE

Wearable device

Wearable devices that are preferentially Food and Drug Administration (FDA) and/or Conformité Européenne (CE) marked

OTHER

Cardiopulmonary resuscitation

Cardiopulmonary resuscitation

OTHER

CT scan, TEE exam, or chest X ray

Chest CT scan, transesophageal echocardiogram (TEE) scans, or chest X ray

Locations (3)

IRCCS Ospedale San Raffaele

Milan, Italy

AOU Policlinico Federico II

Naples, Italy

Azienda Ospedaliera Universitaria Vanvitelli

Naples, Italy