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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Adults (≥ 18 years);

Trial population

* Healthy volunteers (every adult individual with no history of cardiovascular events willing to contribute to the project) and patients who experienced major cardiovascular events (i.e., myocardial infarction or cardiac arrest). Both groups must have worn a wearable device or used a smartphone able to collect healthcare data and biosignals. * Patients ≥18 years resuscitated after cardiac arrest or during ongoing cardiopulmonary resuscitation (CPR). * Patients ≥ 18 years who received a chest CT scan for any reasons.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Wearable device

    Device

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

  • Cardiopulmonary resuscitation

    Other intervention

    Cardiopulmonary resuscitation

  • CT scan, TEE exam, or chest X ray

    Other intervention

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

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Wearable device users1 intervention
Group B: Patients with cardiac arrest2 interventions
Group C: Patients who received a CT scan1 intervention

Trial outcomes

Primary outcomes

1

Survival

Time frame
Hospital discharge (4 weeks for hospital admission)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università Vita-Salute San Raffaele

Lead sponsor

IRCCS Ospedale San Raffaele

Collaborator

Politecnico di Milano

Collaborator

Azienda Ospedaliera Universitaria "Luigi Vanvitelli" (AOV)

Collaborator

Azienda Ospedaliera Universitaria Federico II (AOU Federico II)

Collaborator