Viewing Study NCT06538155



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06538155
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-31

Brief Title: Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation
Sponsor: None
Organization: None

Study Overview

Official Title: Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation the TIME-CARE Project
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TIME-CARE
Brief Summary: Out-of-hospital cardiac arrest OHCA affects 275000 people in Europe every year In Italy alone 50000 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 doesnt 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
Detailed Description: Out-of-hospital cardiac arrest OHCA annually affects 275000 individuals in Europe In Italy alone 50000 persons suffer from OHCA each year and only 9 survives1 Half of the survivors are left with severe brain damage Prompt cardiopulmonary resuscitation CPR and defibrillation before ambulance arrival by bystanders can improve outcomes However in many cases CPR only starts when the ambulance arrives Additionally half of all OHCAs occur in isolation meaning that recognition emergency calls and lifesaving maneuvers are delayed Chest compressions and defibrillation are critical for survival but they are frequently inadequate or not patient-tailored Current CPR guidelines recommend a uniform approach to chest compressions and defibrillation for all patients which fails to account for individual differences To address these unmet medical needs we will develop artificial intelligence algorithms smartphone apps and novel devices Starting with proof-of-concept approaches that we have already conceived we will work to improve recognition of OHCA and provide timely and effective interventions Our goal is to create tools and technologies that can help reduce the burden of OHCA and improve outcomes

First we aim to develop an artificial intelligence algorithm that can predict minutes hours or days in advance major cardiovascular events such as myocardial infarction or cardiac arrest To achieve this we will collect biosignals recorded by wearables to train and validate the algorithm to identify individuals who are at risk of a major cardiovascular event Alerted individuals will seek emergency medical care and receive treatments before a cardiac arrest occurs We also aim to recognize OHCAs that occur in isolation from videos of surveillance cameras

Second to increase the rate of CPR and defibrillation provided before ambulance arrival we will develop a smartphone app that will geolocate and alert nearby citizens to act as first responders The app will also provide guidance on quickly retrieving a defibrillator

Third to determine the optimal compressions and defibrillation position on the chest we will acquire scans of chest computer tomography and transesophageal echocardiography in elective patients and in victims of cardiac arrest This will allow to determine optimal compression and defibrillator pads position understanding the effects on outcomes of different cardiac structures compressed and developing a modern sensor to estimate the optimal compression and defibrillator pads position on the chest

Through experimental simulation and observational studies and a multidisciplinary team of clinicians researchers and engineers we will develop the proof-of-concept of such technologies evaluate their patentability design an exploitation plan and test efficacy in preventing and anticipating recognition of OHCA reducing time to CPR and defibrillation and offering patient-tailored CPR and defibrillation Our underlying hypothesis is that developing novel methods and technologies to enhance each link in the chain of survival preventative measures early recognition timely initiation of CPR and defibrillation and high-quality advanced resuscitation will significantly anticipate lifesaving treatments and reduce the global mortality and disability caused by OHCA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None